Search Results for "harmonization"

April-May 2020 Newsletter

May 30, 2020

 
newsletter | April-May 2020
issue 88
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM to Present at Virtual Conferences in June

 

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavillion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey findings will be made publicly available.

 

Learn more about the DIA Global Meeting here.

 

 
Tufts Study: Lack of Preferred Coverage May be Hurting Biosimilars

 

On May 19th, a study was published in the Journal of the American Medical Association (JAMA) entitled “Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans”. The study was conducted by investigators from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, Massachusetts. They evaluated 535 coverage decisions for biosimilars available in the United States in August 2019.

 

The study found that US health plans granted preferred status to biosimilars in just 14% of coverage decisions, according to a survey of decisions issued by 17 of the largest US commercial health plans, representing approximately 60% of commercially covered patients. By contrast, the reference product was given preferred status in 33% of decisions, and in 53% of decisions, neither the biosimilar nor the reference product was preferred.

 

“The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake”, said the study authors.

 

Read the study here. 

 

 
ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review

 

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:

  • Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
  • Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
  • Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
  • They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
  • Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
  • 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.

Read the full study review and analysis here. 

 

 
Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients
On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.

 

In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).

 

Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:

 

Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.

 

Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.

 

Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.

 

In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.

 

Read the study here and the accompanying editorial here. 

 

 

 
ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:

ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.

 

A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.

 

In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.

 

ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read more about ASBM’s work on the issue of biologic naming here. 

 

Read the full Executive Summary of the 69th INN Consultation here. 

 

 
ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

 

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.

 

It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

 

The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

 

ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.

 

Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.

 

We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.

 

ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.

 

Read ASBM’s comments in full here.

View all submitted comments here. 

 

 
UPCOMING EVENTS

 

EULAR E-Congress 2020

Congress.Eular.org  – June 3, 2020

 

BIO Digital Patient Advocacy Pavilion
https://www.bio.org/events/bio-digital – June 8-12, 2020

 

DIA Global Annual Meeting (Virtual)
DiaGlobal.org – June 14-18, 2020

 

DIA European Meeting 2020

Brussels, Belgium – June 30-July 3, 2020

 

World Drug Safety Congress 2020

Boston, MA – September 1-2, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

April-May 2020 Newsletter

May 30, 2020

 
newsletter | April-May 2020
issue 88
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM to Present at Virtual Conferences in June

 

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavillion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey findings will be made publicly available.

 

Learn more about the DIA Global Meeting here.

 

 
Tufts Study: Lack of Preferred Coverage May be Hurting Biosimilars

 

On May 19th, a study was published in the Journal of the American Medical Association (JAMA) entitled “Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans”. The study was conducted by investigators from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, Massachusetts. They evaluated 535 coverage decisions for biosimilars available in the United States in August 2019.

 

The study found that US health plans granted preferred status to biosimilars in just 14% of coverage decisions, according to a survey of decisions issued by 17 of the largest US commercial health plans, representing approximately 60% of commercially covered patients. By contrast, the reference product was given preferred status in 33% of decisions, and in 53% of decisions, neither the biosimilar nor the reference product was preferred.

 

“The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake”, said the study authors.

 

Read the study here. 

 

 
ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review

 

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:

  • Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
  • Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
  • Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
  • They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
  • Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
  • 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.

Read the full study review and analysis here. 

 

 
Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients
On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.

 

In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).

 

Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:

 

Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.

 

Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.

 

Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.

 

In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.

 

Read the study here and the accompanying editorial here. 

 

 

 
ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:

ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.

 

A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.

 

In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.

 

ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read more about ASBM’s work on the issue of biologic naming here. 

 

Read the full Executive Summary of the 69th INN Consultation here. 

 

 
ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

 

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.

 

It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

 

The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

 

ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.

 

Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.

 

We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.

 

ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.

 

Read ASBM’s comments in full here.

View all submitted comments here. 

 

 
UPCOMING EVENTS

 

EULAR E-Congress 2020

Congress.Eular.org  – June 3, 2020

 

BIO Digital Patient Advocacy Pavilion
https://www.bio.org/events/bio-digital – June 8-12, 2020

 

DIA Global Annual Meeting (Virtual)
DiaGlobal.org – June 14-18, 2020

 

DIA European Meeting 2020

Brussels, Belgium – June 30-July 3, 2020

 

World Drug Safety Congress 2020

Boston, MA – September 1-2, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

February 2020 Newsletter

March 1, 2020

  • newsletter | February 2020
    issue 85
     
     
     

    Who We Are
    The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

     
    Our Perspective
    Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

    For media inquiries please contact: media@safebiologics.org
    Alliance for Safe Biologic Medicines
    PO Box 3691
    Arlington, VA 22203
    (703) 960-0601
    Follow Us

    Twitter: @SafeBiologics

    Facebook

    LinkedIn 

    YouTube 
    FDA Enhances Purple Book to Support Transparency in Biosimilars
    On February 24th, the FDA announced that it will be upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases. The updates will include full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. FDA Commissioner Stephen M. Hahn, M.D. said of the update:

     

    “This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.

    “We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.

    “Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”

     

    Read more about the updates here. 

     

     
    ASBM Conducts 4th 5-Hour CE Course for NY Pharmacists

    On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?“ to a gathering of more than 75 New York-area pharmacists.

     

    The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by ASBM and Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.

     

    The five-hour program consisted of seven presentations, each focusing on an important aspect of biosimilars:

    • ASBM Advisory Board Chair Philip Schneider gave presentations on the basics of biologic and biosimilar medicines; biologic naming and international harmonization efforts; why pharmacists should care about biosimilars; and comparing US biosimilar substitution policy among those of other advanced countries.
    • ASBM Chair Madelaine Feldman, MD, FACR provided a physician perspective on these issues, and supported her comments with recent survey data from prescribers in the U.S. and Europe regarding biologic naming and substitution policies.
    • ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, provided a patient advocate’s perspective on biosimilars, with an emphasis on the issue of non-medical switching.
    • Dan Tomaszewski, PhD, PharmD, Assistant Professor at Chapman University College of Pharmacy, examined the role of pharmacists in biosimilar use, and discussed pharmacist-specific considerations of dealing with PBMs, insurers, and patients.

    Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists. These included inaugural ASBM Chair Richard Dolinar, MD; Immediate Past Chair Harry Gewanter MD FACR; and ASBM Steering Committee member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.

     

    Read a detailed description of the program and view all the presentations and videos here. 

     

     
    ASBM, Gastrointestinal Society Submit Joint Comments on Canadian Pricing Proposal

     

    On February 14th, ASBM and the Gastrointestinal Society jointly submitted formal comments on the Canadian Patented Medicine Pricing Review Board (PMPRB) Draft Guidelines, as part of a stakeholder consultation by the PMPRB. From the comments:

     

    As advocates representing millions of Canadian patients, the Alliance for Safe Biologic Medicines (ASBM) appreciates the opportunity to comment on the PMPRB’s new Draft Guidelines. ASBM is a global alliance of patient advocacy organizations and physician societies, working to promote patient-centered biosimilar policies worldwide.
    The Gastrointestinal Society is one of our leading Canadian members, and represents as many as 6 million Canadians with irritable bowel syndrome (IBS), more than 9 million with functional dyspepsia, as many as 8 million with chronic acid reflux (GERD), and an additional 233,000 suffering from chronic inflammatory bowel disease (Crohn’s and ulcerative colitis).
    We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.
    However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.
    It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.

     

    Read ASBM’s and the Gastrointestinal Society’s joint comments in their entirety here. 

     
    FDA Announces Increased Collaboration with FTC to Address Anti-Competitive Practices in Biosimilar Market. 

     

    On February 3rd, the U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
    “Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

     

    “Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”

     
    Draft Guidance and Comment Period

     

    The FDA has published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

     

    These announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

    The FDA is accepting comments from the public on the draft guidance from February 4 to April 6.

     

    Comments may be submitted here. 

     

     
    UPCOMING EVENTS

     

    DIA European Meeting 2020

    Brussels, Belgium – March 17-19, 2020

     

    WHO 70th INN Consultation

    Geneva, Switzerland – April 21, 2020
    Digestive Disease Week

    Chicago, IL – May 2-5, 2020

     

     

     

February 2020 Newsletter

March 1, 2020

  • newsletter | February 2020
    issue 85
     
     
     

    Who We Are
    The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

     
    Our Perspective
    Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

    For media inquiries please contact: media@safebiologics.org
    Alliance for Safe Biologic Medicines
    PO Box 3691
    Arlington, VA 22203
    (703) 960-0601
    Follow Us

    Twitter: @SafeBiologics

    Facebook

    LinkedIn 

    YouTube 
    FDA Enhances Purple Book to Support Transparency in Biosimilars
    On February 24th, the FDA announced that it will be upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases. The updates will include full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. FDA Commissioner Stephen M. Hahn, M.D. said of the update:

     

    “This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.

    “We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.

    “Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”

     

    Read more about the updates here. 

     

     
    ASBM Conducts 4th 5-Hour CE Course for NY Pharmacists

    On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?“ to a gathering of more than 75 New York-area pharmacists.

     

    The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by ASBM and Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.

     

    The five-hour program consisted of seven presentations, each focusing on an important aspect of biosimilars:

    • ASBM Advisory Board Chair Philip Schneider gave presentations on the basics of biologic and biosimilar medicines; biologic naming and international harmonization efforts; why pharmacists should care about biosimilars; and comparing US biosimilar substitution policy among those of other advanced countries.
    • ASBM Chair Madelaine Feldman, MD, FACR provided a physician perspective on these issues, and supported her comments with recent survey data from prescribers in the U.S. and Europe regarding biologic naming and substitution policies.
    • ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, provided a patient advocate’s perspective on biosimilars, with an emphasis on the issue of non-medical switching.
    • Dan Tomaszewski, PhD, PharmD, Assistant Professor at Chapman University College of Pharmacy, examined the role of pharmacists in biosimilar use, and discussed pharmacist-specific considerations of dealing with PBMs, insurers, and patients.

    Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists. These included inaugural ASBM Chair Richard Dolinar, MD; Immediate Past Chair Harry Gewanter MD FACR; and ASBM Steering Committee member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.

     

    Read a detailed description of the program and view all the presentations and videos here. 

     

     
    ASBM, Gastrointestinal Society Submit Joint Comments on Canadian Pricing Proposal

     

    On February 14th, ASBM and the Gastrointestinal Society jointly submitted formal comments on the Canadian Patented Medicine Pricing Review Board (PMPRB) Draft Guidelines, as part of a stakeholder consultation by the PMPRB. From the comments:

     

    As advocates representing millions of Canadian patients, the Alliance for Safe Biologic Medicines (ASBM) appreciates the opportunity to comment on the PMPRB’s new Draft Guidelines. ASBM is a global alliance of patient advocacy organizations and physician societies, working to promote patient-centered biosimilar policies worldwide.
    The Gastrointestinal Society is one of our leading Canadian members, and represents as many as 6 million Canadians with irritable bowel syndrome (IBS), more than 9 million with functional dyspepsia, as many as 8 million with chronic acid reflux (GERD), and an additional 233,000 suffering from chronic inflammatory bowel disease (Crohn’s and ulcerative colitis).
    We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.
    However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.
    It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.

     

    Read ASBM’s and the Gastrointestinal Society’s joint comments in their entirety here. 

     
    FDA Announces Increased Collaboration with FTC to Address Anti-Competitive Practices in Biosimilar Market. 

     

    On February 3rd, the U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
    “Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

     

    “Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”

     
    Draft Guidance and Comment Period

     

    The FDA has published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

     

    These announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

    The FDA is accepting comments from the public on the draft guidance from February 4 to April 6.

     

    Comments may be submitted here. 

     

     
    UPCOMING EVENTS

     

    DIA European Meeting 2020

    Brussels, Belgium – March 17-19, 2020

     

    WHO 70th INN Consultation

    Geneva, Switzerland – April 21, 2020
    Digestive Disease Week

    Chicago, IL – May 2-5, 2020

     

     

     

ASBM Presents Fourth 5-Hour CE Course to NY Pharmacists

February 29, 2020

On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?” to a class consisting of more than 75 New York area pharmacists. The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018. liu-0

The course began with pre-course learning assessment questions presented by Joseph Bova, RPh, Director of Continuing Education for LIU-Pharmacy, and ASBM Advisory Board Chair Philip Schneider, MS FASHP FFIP.  The program consisted of seven presentations, each focusing on one important aspect of biosimilars. Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists, including inaugural ASBM Chair Richard Dolinar,  MD; immediate past Chair Harry Gewanter MD FACR; and ASBM Steering Committee Member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.

liu-2

Presentation 1: Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines

In the first presentation, Dr. Schneider begins by explaining what biologic medicines are, how they were developed and approved, and how they are used to treat serious conditions including rheumatoid arthritis and cancer. He then explains safety, storage and handling considerations that result from the greater size, complexity, and sensitivity of biologics, relative to small molecule drugs.

liu1

He follows with a discussion of biosimilars, discussing differences between biosimilars and chemical generics- chief among them that biosimilars are not identical but only highly similar to their reference products. In addition, he discusses differences between the approval processes of generics, biosimilars, and originator biologics, emphasizing the importance of improved pharmacovigilance for products with abbreviated approval pathways.

View Dr. Schneider’s presentation here.  

Video 1: Approval and Interchangeability

Video 2: Benefits of Biosimilars

Presentation 2: Physician Perspectives on Biosimilars
Madelaine Feldman, MD, FACR
Chair, Alliance for Safe Biologic Medicines

In this presentation, Dr. Feldman discusses physician perspectives on four key biosimilar policy issues affecting medical and pharmacy practice: Naming, Interchangeability and Substitution, Non-Medical Switching, and Increasing Biosimilar Uptake.

Dr. Feldman began with a discussion of ASBM, its surveys and its work bringing the patient, physician and pharmacist perspectives to regulators worldwide. This includes ASBM’s history of participations in the WHO INN Consultations and its recent discussion forums on biosimilar naming in which the WHO, FDA, and Health Canada participated.

Regarding naming, Dr. Feldman discussed the importance to physicians worldwide of distinct naming for all biosimilars. Support for distinguishable biologic naming varies from 68% to 94% depending on country and region. She noted that significant percentages of physicians globally use the nonproprietary name when recording the prescribed biologic medicine in the patient record, which could result in the patient receiving the wrong medicine. Similarly, significant percentages of physicians worldwide use only the nonproprietary name when recording adverse events; which could result in their misattribution to the incorrect product.

Regarding substitution, Dr. Feldman emphasized the importance to physicians of communication from the pharmacist in the event of a biosimilar substitution; and of retaining the authority to prevent a substitution they deem medically inappropriate by using “dispense as written” (DAW). She also clarified that the U.S.-specific standard of “interchangeability”-applied to biosimilars suitable for pharmacy-level substitution-  is not intended to be transitive. That is to say, even if biosimilar A and biosimilar B are both interchangeable with the same reference product, they are not interchangeable with each other. Dr. Feldman also discussed physician concerns with the non-medical switching of patients on biologics- switching these patients’ medicine for non-medical reasons. This is typically done by an insurer or PBM for cost or other financial reasons. Treatment decisions, including which biologic to use and if and when to switch, should be made by the patient in consultation with his or her healthcare team, rather than a third party payer, Dr. Feldman emphasized. She also discussed the example of two Canadian provinces which have recently begun the mass non-medical switching of thousands of their patients, and how the gastroenterologist community in particular has responded and expressed its concerns with this policy.

liu-4

Dr. Feldman shared data from ASBM’s recent survey of 579 European prescribers of biologics, which showed these prescribers have high confidence in biosimilars, but nevertheless consider it extremely important to retain physician and patient control over treatment decisions: A strong majority of respondents (82%) considered it “Very Important” or “Critical” to decide which biologic medicine is dispensed to their patients, an increase from 72% in the 2013 survey. In addition, 84% consider the authority to prevent a substitution either “Very Important” or “Critical”, an increase from 74% in the 2013 survey. While 84% of physicians were comfortable prescribing biosimilars to new patients, the comfort level drops to 60% when switching stable patients to a biosimilar. 58% of physicians were uncomfortable switching patients to a biosimilar for economic rather than health reasons. If the non-medical switch were made by a third party, 73% would be uncomfortable.

Finally, Dr. Feldman discussed ways to increase biosimilar uptake- including an explanation of the physician’s cautious approach to choosing a medicine. Data showing safe use and safe switching of stable patients, she noted, are critical to building physician confidence. Distinct naming also reassures physicians that these products can be used safely and their effects tracked accurately.

liu5

Yet many of the obstacles to biosimilar uptake are commercial, and more approvals and lower cost does not translate to greater access for patients. For example, while 26 biosimilars are approved, only about half are currently available.

ImagePatent litigation is common, which can result in delayed introduction of biosimilars. Finally, manufacturer rebate arrangements mean that PBMs may not give the lowest cost product preferred placement, posing a further- and more significant- barrier to uptake.

View Dr. Feldman’s presentation here.

Video 3: Pharmacists and Biologic Naming

Presentation 3: Biologic and Biosimilar Naming: Pharmacist Perspectives and International Harmonization
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines

In this presentation, Dr. Schneider discussed considerations in the naming of biologics, including biosimilars, and the benefits of distinct naming. He described naming systems in use around the world, including the FDA’s four-letter suffix system, and the WHO’s proposed biologic qualifier or “BQ” system, which would also use a four-letter suffix if implemented. He shared survey data from ASBM and the Academy of Managed Care Pharmacy showing strong support among US pharmacists for distinct naming. He discussed the importance of having multiple, redundant layers of “defenses” in pharmacovigiliance and how this concept can be applied to distinct naming, and how different regulators around the world are approaching this problem, with varying degrees of effectiveness.

liu6

He also examined the benefits of and progress toward international harmonization of biologic nomenclature, including ASBM’s work with the WHO’s INN Programme. He highlighted perspectives gathered at ASBM’s April 2018, July 2018, and March 2019 forums at which FDA , Health Canada, WHO, and other stakeholders met to discuss the need for harmonization. Finally, Dr. Schneider discussed his work with the International Pharmaceutical Federation (FIP) which has begun addressing the issue of distinct biologic naming in its policy guidelines and its educational sessions.

View Dr. Schneider’s presentation here.

 

Presentation 4: Why Should Pharmacists Care About Biosimilars? 

Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines

In this presentation, Dr. Schneider examines why biosimilars are relevant to the pharmacy profession. First, he examines rising drug costs, much of which are driven by the cost of biologic medicines. Biosimilars, he explains, can be a tool to control these costs. However, biosimilars are not generics, and savings are not as high as with generics. In addition, significant discounts are not automatic- it is important to maintain competition between multiple products. Lessons from European biosimilar markets show this creates downward pressure on prices, without disincentivizing either innovator of biosimilar production. Other issues raised were the declining autonomy of healthcare professionals- where gag orders, preferential treatment of products by payers, or other financial incentives such as gain-sharing can distort the normal process of treatment decision-making. Dr. Schneider believes that the role of health care providers is to act as “learned intermediaries” in treatment decision-making. In effect, they are able to balance patient-specific factors against the the considerations of broad populations of patients- which are the primary focus of government regulators and private payers.

Read Dr. Schneider’s presentation here.

 

Presentation 5: Biosimilars: The Patient Advocate’s Perspective
Andrew Spiegel
Executive Director, Global Colon Cancer Association

Mr. Spiegel spoke about his experience as a patient advocate following the death of his parents from cancer. Today, he explained, the life expectancy of patients diagnosed with colon cancer has tripled, in part due to biologic medicines. Biosimilars, Mr. Spiegel emphasized, hold great promise for patients- offering new therapeutic options and doing so at lower cost. However, he cautioned that the benefits of biosimilars will not be realized unless they gain the confidence of providers and patients.

A key topic Mr. Spiegel discussed is Non-Medical Switching.  The choice to use an innovator biologic or biosimilar, must always be made by the patient and physician, rather than a third-party payer.

liu8

“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel. He then outlined practices that payers may use to force a patient to switch to a non-interchangeable biosimilar, such as changing their medical coverage or health care premiums.

liu7He also discussed the situation in Canada, where two provinces recently announced that they would be forcibly switching 50,000 patients from the medicine they and their physicians chose to a government-chosen biosimilar. “This is not how patients in Europe are treated. In nearly every country, new patients are encouraged to try the lower-cost biosimilar, but the physician and patient choose the medicine they want, and the payer will continue to reimburse it.”

liu-aspharmacistsPharmacists, Spiegel said, serve an important role in patient care and should be well-informed by transparent, informative product labeling regarding a biosimilar’s approval, especially regarding indication extrapolation: “Pharmacists are the last line of defense for patients, the last link in the chain…they should give informed advice to patients about the benefits of biosimilars, as well as helping track possible adverse events.”

View Mr. Spiegel’s presentation here.

Video 4: Non-Medical Switching: What to Physicians and Patients Think?

Video 5: Pharmacists and Non-Medical Switching

Presentation 6: Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Philip J. Schneider, MS, FASHP
Advisory Board Chair, Alliance for Safe Biologic Medicines

The next presentation was given by Dr. Schneider, and dealt with biosimilar substitution policy in the United States. Dr. Schneider emphasized that while Congress sets the legal definition of interchangeability, and the FDA makes the scientific determination of which biosimilars are interchangeable, it is the individual States that govern when and how a pharmacist can substitute an interchangeable biosimilar.

Following a brief discussion about substitution policy globally (including Canada, the EU, Latin America, and Australia) Dr. Schneider spoke about the evolution of biosimilar substitution legislation in the US.

liu-3

He focused his discussion on laws passed by 46 states and Puerto Rico which require a pharmacist to communicate to the prescribing physician which product- the originator or the biosimilar- was actually dispensed to the patient. These states also allow a physician to specify “do not substitute” or “dispense as written” in order to prevent a substitution they consider medically inappropriate.

A collaborative and communicative approach to pharmacovigilance, Schneider argued, is good for everyone. It empowers the pharmacist to offer the patient new and lower-cost treatment options, it allows the patient to be an engaged partner in a their own care, it allows the physician to maintain an accurate patient record and make informed treatment decisions, and it improves safety overall by promoting accurate attribution of adverse events to the proper medicine.

View Dr. Schneider’s presentation here.

 

Presentation 7: Pharmacists and Biosimilars: The Role of Pharmacists in Managing Biosimilar Use
Daniel Tomaszewski, RPh, Phd
Assistant Professor in Pharmacy Administration, Chapman University

In this presentation, Dr. Tomaszewski discusses the role of pharmacists in collaboratively managing patient care regarding biologics. This includes managing prior authorizations from PBMs, and dealing with patient use concerns including ensuring adherence and increasing familiarity with biosimilars. He discussed his work with AMCP on a 2016 study that showed strong support for distinct names for biosimilars. He emphasized the importance of real world evidence (RWE) in building confidence in biosimilars, and the importance of pharmacists in gathering it.

 

liu-9

Echoing the concerns of many physicians, Dr. Tomaszewski discussed the impact of post-approval barriers to biosimilar access including patent litigation and payer policies. He concluded with proposals on how to improve education on biosimilars, including a need to focus on providing fact driven data, to encourage better pharmacist engagement in specialty drug utilization, to ensure appropriate medicinal chemistry, pharmacologic, and therapeutic understanding of biologic agents, and to become knowledgeable about coverage/formulary/utilization management strategies likely to be put in place.

View Dr. Tomaszewski’s presentation here.

liu-10

liu-11

The course concluded with a Q+A session with a panel featuring all presenters, followed by a learning assessment in which attendees were quizzed about what they had learned throughout the five-hour program.

January 2020 Newsletter

February 25, 2020

newsletter | January 2020
issue 84
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM Submits Comments in Canadian Biosimilar Stakeholder Consultation Period 
On January 13th, the third and final phase of a stakeholder consultation on Canadian biosimilar policy closed. The consultation was conducted by the Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) to develop recommendations for the use and implementation of biosimilars.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase was an online survey, which closed on January 13, 2020.

 

ASBM submitted comments with other Canadian stakeholders in the patient and physician communities who are concerned with Canadian biosimilar policy. Michael Reilly, executive director of ASBM, summarized the group’s position:

 

Biosimilars can be a valuable tool in controlling health costs, but it is critical that treatment decisions continue to be made by patients and their physicians, not by politicians. This is particularly true in the case of patients who are well-treated and stable on their current medications.

Moreover, the economic benefits of biosimilars need not come at the cost of patients receiving the medicine their physician chooses to best meet their needs. European countries, for example, enjoy a robust and competitive biosimilars market, with significant savings.

Nearly every country in Europe will reimburse whichever biologic the physician prescribes – whether it’s an originator biologic or a biosimilar. No European country has a forced-substitution policy enacted by government fiat (as recently seen in British Columbia and Alberta.) We urge Canadian provinces to pattern their substitution practices on the patient-friendly, physician-centered, and pro-competition policies that have proven so successful in Europe.

 

Read more about the consultation process here:  https://www.biosimilarsconsultation.ca/the-process.

 

 
FDA Highlights Biosimilar Approvals in 2019 Annual Report

In early January, The FDA’s Center for Drug Evaluation and Research’s (CDER) released its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals,” The report covers CDER’s notable new drug approvals and illustrates the Center’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
CDER approved 48 novel medicines and 10 biosimilars during 2019, according to the report. Janet Woodcock, MD, director of CDER, praised the FDA’s success in biosimilar approvals, saying:

 

“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.”

 

SInce its first approval in March 2015, the FDA has approved 26 biosimilars. The most recent approval, in December 2019, was for Avsola (infliximab-azzq), the fourth biosimilar for Remicade (infliximab).

 

Read the CDER Annual Report here.

 
 

Patient Advocates, Opposition Party Criticize Alberta Government’s Forced-Switch Policy

 

On January 15th, a dozen patient advocates gathered at the Alberta Federal Building to urge the government of Alberta to halt implementation of a controversial forced-biosimilar-substitution policy announced December 12th. Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug before July 1, 2020. This mirrors a policy recently enacted in British Columbia which has drawn criticism from the Canadian Association of Gastrenterology and numerous patient organizations.

 

One patient expressed how she was “shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs”.

 

The patients were joined by Alberta’s NDP opposition health critic David Sheperd, who called on the government to reverse  a policy he characterized as having been “botched” and which creates “a real risk for some of these folks of returning to be sick and incapacitated”.

 

“It’s important to introduce biosimilars (to new patients),” Sheperd said. “I recognize that there are indeed costs that we need to reckon with and I think it’s reasonable for government to move forward.
“My disagreement is with the manner in which it is moving forward: chaotic, rushed, not thought through, not considering long-term potential consequences.”

Read more here. 

 
WHO Publishes Executive Summary of 69th INN Consultation

The World Health Organization recently published the Executive Summary of the 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, which took place on October 22nd, 2019 in Geneva, Switzerland.

 

ASBM participated in the Consultation, and was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. This was the thirteenth INN Consultation at which ASBM has presented.

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June 2019.

 

The INN Committee’s Executive Summary of the Open Session for Stakeholders reflected several of the key points made in ASBM’s presentation, including:

  • A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively.
  • ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number.
  • Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
  • [ASBM] felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now.
  • [ASBM] felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read the complete Executive Summary here. 

 

 
UPCOMING EVENTS

 

LIU-Pharmacy CE Course
Queens, NY – February 23, 2020

Festival of Biologics USA

San Diego, CA – March 2-4, 2020

 

DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

WHO 70th INN Consultation

Geneva, Switzerland – April 21, 2020

 

 

 

January 2020 Newsletter

February 25, 2020

newsletter | January 2020
issue 84
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM Submits Comments in Canadian Biosimilar Stakeholder Consultation Period 
On January 13th, the third and final phase of a stakeholder consultation on Canadian biosimilar policy closed. The consultation was conducted by the Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) to develop recommendations for the use and implementation of biosimilars.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase was an online survey, which closed on January 13, 2020.

 

ASBM submitted comments with other Canadian stakeholders in the patient and physician communities who are concerned with Canadian biosimilar policy. Michael Reilly, executive director of ASBM, summarized the group’s position:

 

Biosimilars can be a valuable tool in controlling health costs, but it is critical that treatment decisions continue to be made by patients and their physicians, not by politicians. This is particularly true in the case of patients who are well-treated and stable on their current medications.

Moreover, the economic benefits of biosimilars need not come at the cost of patients receiving the medicine their physician chooses to best meet their needs. European countries, for example, enjoy a robust and competitive biosimilars market, with significant savings.

Nearly every country in Europe will reimburse whichever biologic the physician prescribes – whether it’s an originator biologic or a biosimilar. No European country has a forced-substitution policy enacted by government fiat (as recently seen in British Columbia and Alberta.) We urge Canadian provinces to pattern their substitution practices on the patient-friendly, physician-centered, and pro-competition policies that have proven so successful in Europe.

 

Read more about the consultation process here:  https://www.biosimilarsconsultation.ca/the-process.

 

 
FDA Highlights Biosimilar Approvals in 2019 Annual Report

In early January, The FDA’s Center for Drug Evaluation and Research’s (CDER) released its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals,” The report covers CDER’s notable new drug approvals and illustrates the Center’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
CDER approved 48 novel medicines and 10 biosimilars during 2019, according to the report. Janet Woodcock, MD, director of CDER, praised the FDA’s success in biosimilar approvals, saying:

 

“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.”

 

SInce its first approval in March 2015, the FDA has approved 26 biosimilars. The most recent approval, in December 2019, was for Avsola (infliximab-azzq), the fourth biosimilar for Remicade (infliximab).

 

Read the CDER Annual Report here.

 
 

Patient Advocates, Opposition Party Criticize Alberta Government’s Forced-Switch Policy

 

On January 15th, a dozen patient advocates gathered at the Alberta Federal Building to urge the government of Alberta to halt implementation of a controversial forced-biosimilar-substitution policy announced December 12th. Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug before July 1, 2020. This mirrors a policy recently enacted in British Columbia which has drawn criticism from the Canadian Association of Gastrenterology and numerous patient organizations.

 

One patient expressed how she was “shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs”.

 

The patients were joined by Alberta’s NDP opposition health critic David Sheperd, who called on the government to reverse  a policy he characterized as having been “botched” and which creates “a real risk for some of these folks of returning to be sick and incapacitated”.

 

“It’s important to introduce biosimilars (to new patients),” Sheperd said. “I recognize that there are indeed costs that we need to reckon with and I think it’s reasonable for government to move forward.
“My disagreement is with the manner in which it is moving forward: chaotic, rushed, not thought through, not considering long-term potential consequences.”

Read more here. 

 
WHO Publishes Executive Summary of 69th INN Consultation

The World Health Organization recently published the Executive Summary of the 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, which took place on October 22nd, 2019 in Geneva, Switzerland.

 

ASBM participated in the Consultation, and was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. This was the thirteenth INN Consultation at which ASBM has presented.

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June 2019.

 

The INN Committee’s Executive Summary of the Open Session for Stakeholders reflected several of the key points made in ASBM’s presentation, including:

  • A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively.
  • ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number.
  • Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
  • [ASBM] felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now.
  • [ASBM] felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read the complete Executive Summary here. 

 

 
UPCOMING EVENTS

 

LIU-Pharmacy CE Course
Queens, NY – February 23, 2020

Festival of Biologics USA

San Diego, CA – March 2-4, 2020

 

DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

WHO 70th INN Consultation

Geneva, Switzerland – April 21, 2020

 

 

 

November 2019 Newsletter

December 13, 2019

newsletter | November 2019
issue 82
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM Chair Participates in Webinar on Patient Access

 

On November 21st, ASBM Chair Madelaine Feldman, MD, FACR participated in a webinar hosted by the Patient Access Collaborative, to discuss the topic of utilization management (UM) techniques employed by third-party payers.

 

UM techniques include formulary constructions and other practices intended to reduce health plan or pharmaceutical benefit manager (PBM) spending on medications including biologic medicines, or which otherwise restrict patients’ access to these medications by requiring additional permissions, forms, and/or medicines.

 

These tools, as Dr. Feldman explained, can interfere with the practice of medicine and limit patient access to preferred treatments. They also create an administrative burden for provider offices that require significant resources to fulfill payer requirements on behalf of patients.

 

 
FDA Approves 25th Biosimilar, Its 9th Approval this Year

 

On November 15th, Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, released a statement regarding the FDA’s great progress in biosimilar approvals since its first approval four and a half years ago in March 2015. From the statement:

 

Today the FDA took another step to further foster biologics competition with the approval of Abrilada (adalimumab – afzb), a biosimilar to Humira. Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25. I’m pleased to see this progress and am confident that the market for these therapies will continue to grow. To date, 74 programs for 38 different reference products have been enrolled in our Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.

 

Read the full statement here.

 

 
ASBM Chair at Healio.com: PBM Rebate System “Perfectly Legal, Perfectly Wrong”

A November 19th op-ed by ASBM Chair Madelaine Feldman, MD, FACR sheds some light on a major commercial barrier to biosimilar uptake, one in which paradoxically, competition often means higher, rather than lower drug prices: the Pharmaceutical Benefit Manager (PBM) rebate system:

 

[PBMs] create the formularies that determine what drugs will be paid for, when they can be taken, where they can be purchased and how much they will cost the patient. Obviously, this becomes very important for our expensive rheumatologic medications because, if an expensive medicine is not on the formulary, it is completely unaffordable for patients.

 

To get the coveted “preferred” status on the formulary, manufacturers send in secret kickback package bids to the PBMs. The highest kickback package amount wins the prize of “preferred” status, meaning patients must step through the winner’s drug before taking the less preferred drugs. This gives automatic market share to the winning kickback package bidder.

 

The greater the market share and the number of indications a drug has, the more leverage that manufacturer has to control the formulary…It is easy to see that the higher the price of your drug, the better your kickback package looks to the PBM. Remember that competition in this system raises prices, just like at an art auction when everyone is bidding on that same coveted work of art.

 

Read the entire op-ed here. 

 

 
ASBM Exhibits at ACR/ARP Annual Meeting

 

From November 10-12, ASBM exhibited at the ACR/ARP Annual Meeting in Atlanta, Georgia. Nearly 16,000 rheumatologists, rheumatology health professionals, fellows-in-training, and exhibitors from more than 100 countries attended the event. ASBM was represented at the meeting by Chair Madelaine Feldman, MD, FACR; Immediate Past Chair Harry Gewanter, MD MACR; and Executive Director Michael Reilly, each of whom spent time at ASBM’s booth and met with conference attendees.

 

At ASBM’s booth literature was distributed which covered many key biosimilar policy issues which affect rheumatology practice. These included data showing strong support among U.S. physicians for FDA’s recent policy update on biologic naming, a fact sheet discussing what can be learned from the European biosimilar substitution experience, the abstract for ASBM’s forthcoming GaBI Journal whitepaper on features of European biosimilar markets that contribute to their famously high uptake levels, and a poster recently shared at the ESMO conference in Barcelona which featured findings from ASBM’s recent survey of 579 European physicians.

 

Read more about the ACR Annual Meeting here.

 

 
First Rituximab Biosimilar in U.S. Launches at 10% Discount

 

On November 7th, biosimilar manufacturers Teva and Celltrion  announced that Truxima (rituximab-abbs), the first biosimilar to Genentech’s Rituxan (rituximab), will be available in the U.S. starting November 11th. The biosimilar sells at a 10% discount over the originator product.

 

Like its reference product, Truxima is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

 

Read more about the approval here.

 
ASBM Exhibits at DIA Annual Canadian Meeting

 

On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers.

 

Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development. Session topics included the patient experience, international collaboration, and the use of real-world evidence in safety and efficacy monitoring.

 

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, MS FASHP FFIP. At ASBM’s booth, Schneider met with conference attendees, including several Health Canada officials, to discuss ASBM’s work. Policy issues discussed included the importance of distinct biologic nomenclature in pharmacovigilance, efforts toward international harmonization of biologic nomenclature, and emerging biosimilar substitution policies in Canada.

 

ASBM also used the meeting as an opportunity to discuss potential lessons that could be learned from European countries. While some Canadian provinces have adopted or are considering forced biosimilar subsitution European countries enjoy high biosimilar uptake rates and have overwhelmingly rejected such policies.

 

While at DIA Canada, ASBM released the abstract of a forthcoming whitepaper on the European biosimilars experience, co-authored by Dr. Schneider and ASBM executive director Michael Reilly.

 

The paper examines the policies which led to Europe’s success- including preserving physician choice and promoting competition between multiple products:

 

“Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

 

The abstract was available at the ASBM booth, as was a new fact sheet, entitled “What Can Canada Learn From the European Biosimilar Experience?”, which incorporates findings from the whitepaper, data from ASBM’s recent survey of 579 European physicians, and the perspectives of Canadian physicians and patient advocacy organizations on substitution policy.

 

View the fact sheet here.

 

 
UPCOMING EVENTS
Festival of Biologics USA

San Diego, CA – March 2-4, 2020

 

DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

American Society of Clincial Oncology (ASCO) Annual Meeting

Chicago –  May 29 -June 2, 2020

 

EULAR European Congress of Rheumatology 2020

Frankfurt, Germany – June 3-6, 2020

 

 

ASBM Exhibits at DIA Annual Canadian Meeting

November 8, 2019

On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers.  Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development. Session topics included the patient experience, international collaboration, and the use of real-world evidence in safety and efficacy monitoring.

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, MS FASHP FFIP. At ASBM’s booth, Schneider met with conference attendees, including several Health Canada officials, to discuss ASBM’s work. Policy issues discussed included the importance of distinct biologic nomenclature in pharmacovigilance, efforts toward international harmonization of biologic nomenclature, and emerging biosimilar substitution policies in Canada.

With Canadian provinces beginning to adopt their own biosimilar substitution policies, ASBM also used the Meeting as an opportunity to discuss potential lessons that could be learned from European countries. While at DIA Canada, ASBM released the abstract of a forthcoming whitepaper on the European biosimilars experience, co-authored by Dr. Schneider and ASBM executive director Michael Reilly. The paper examines the policies which led to Europe’s success- including preserving physician choice and promoting competition between multiple products:

“Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

The abstract was available at the ASBM booth, as was a new fact sheet, entitled “What Can Canada Learn From the European Biosimilar Experience?”, which incorporates findings from the whitepaper, data from ASBM’s recent survey of 579 European physicians, and the perspectives of Canadian physicians and patient advocacy organizations on substitution policy.

img_0356
ASBM Advisory Board Chair Philip Schneider (right) discusses biosimilar policy with a Health Canada official.

 

 

 

October 2019 Newsletter

November 1, 2019

newsletter | October 2019
issue 81

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
GaBI Journal Publishes Abstract of ASBM’s Forthcoming Whitepaper on European Biosimilar Market

 

On October 30th, the Journal of the Generics and Biosimilar Initiative (GaBI Journal) published the abstract of ASBM’s forthcoming whitepaper on the evolution of the European biosimilar market. The whitepaper, co-authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, will be published in the next issue of Gabi Journal. From the abstract:

 

“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

 

In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.

 

Mr. Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.

 

Read the abstract of the forthcoming whitepaper here. 

 

 
ASBM Participates in European Commission Biosimilars Meeting

 

On October 30th, ASBM participated in the fifth annual “Stakeholder Event on Biosimilar Medicinal Products” held in Brussels, Belgium.

The day-long multi-stakeholder event was organized by the European Commission and the European Medicines Agency (EMA).

 

Participants included representatives of public authorities, patients’ organizations, healthcare professionals, and pharmaceutical companies. They shared their best practices and clinical experiences with biological medicines, including biosimilars.

 

Topics included the uptake of biosimilars in oncology, sustainable procurement practices, and how to improve the understanding of biosimilars.

 

Read more about the Stakeholder Event here. 

 
ASBM Presents to WHO, Urging Action on International Harmonization of Biologic Naming

On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme,  the Executive Summary from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.

 

Read more about ASBM’s work on international harmonization of global nomenclature here. 

 

 
ASBM Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?

 

On October 28th, ASBM posted a fact sheet entitled “What Can Canada Learn from the European Biosimilar Experience?” to serve as a resource as Canadian provinces, including British Columbia and Alberta, look to duplicate Europe’s success with biosimilars.

 

The undisputed global leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).

 

The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia:

 

B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to this success.

 

It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced switching mandates, but through preserving choice for physicians and patient and promoting ongoing competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.

 

Not only does the B.C policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.

 

The fact sheet also reflects concerns raised with the BC policy by Canadian physicians and patient advocates. In addition, it includes data from ASBM’s 2017 survey of Canadian physicians, showing strong opposition to the third-party switching of stable patients for non-medical (e.g. cost) reasons, as happens under the B.C. policy.

 

View the fact sheet here.

 

 
ASBM Presents at Biosimilar World Congress: Europe 2019

 

On October 15th and 16th, ASBM participated in the Biosimilar World Congress: Europe 2019, part of the three-day Festival of Biologics held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association.

 

On the first day, Dr. Schneider participated in a panel entitiled “Increasing Global Patient Access to Biosimilars”. In his presentation, Dr. Schneider emphasized the role that clinicians, including physicians and pharmacists, can play as “learned intermediaries” who can balance patient-specific factors against the objectives of the pharmaceutical industry and of regulators.

 

Robust pharmacovigilance is also important to increase biosimilar confidence and uptake, said Schneider:

 

“With the reliance on analytics over clinical trials for market approval there is a need for real-world evidence, including strong pharmacovigilance programs. There is general agreement that these programs are not sufficiently strong, including in Europe. This would support the need for a common language with which we communicate clinical experience with biologics and biosimilars – for example, a global system of distinguishable non-proprietary names, as the WHO has proposed.”

 

On day two, Andrew Spiegel participated in a panel entitled “Stakeholder Collaboration for Biosimilar Sustainability”. In the discussion, Mr. Spiegel emphasized the importance of education to increase physician familiarity and comfort, but also highlighted the importance of not bypassing or excluding the physician from treatment decisions.

 

Spiegel cited the example of British Columbia, whose Health Minister cited Europe’s high uptake rates, yet pushed policies that Europe largely rejects. These include forced biosimilar substitution, third-party switching of stable patients for non-medical reasons, and elimination of reimbursement of an originator biologic by government fiat.

 

Mr. Spiegel emphasized that most European countries enjoy high biosimilar rates while preserving physician autonomy. Most European countries do not allow automatic substitution, and reimburse for whichever among multiple products the physician prescribes, including the originator. Only Denmark reimburses only the winning product, following a transparent national tender process. Norway also has a national tender, but allows physicians to prescribe- and continues to reimburse- innovator products.

 

Read more about ASBM’s participation in the conference here. 

 
UPCOMING EVENTS

 

ASHP Midyear Clinical Meeting 

Las Vegas, NV – December 8-12, 2019
DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

American Society of Clincial Oncology (ASCO) Annual Meeting

Chicago –  May 29 -June 2, 2020

 

EULAR European Congress of Rheumatology 2020

Frankfurt, Germany – June 3-6, 2020