Search Results for "harmonization"

ASBM Presents at WHO’s 73rd INN Consultation

October 25, 2021

On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated.

ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

While the discussions at the INN Consultation are confidential pending publication of an Executive Summary by the INN Programme, the Executive Summary from the 72nd INN Consultation – held April 13th, 2021 and in which ASBM also participated – may be viewed here. From that report:

“Many published reports, including ASBM’s own surveys of prescribers over several years, show a clear lack of identification of the brand name in ADR reports, especially in the EU in which brand name reporting became a mandatory requirement in 2012.”

“ASBM highlighted that reporting on brand names in ADR reports continues to be inadequate despite widespread recognition of its importance. WHO has identified a lack of a naming standard as a regulatory challenge that undermines the strong pharmacovigilance needed for biologics and biosimilars, and ASBM underlined that the WHO has the ability and the duty to make a global standard available to address this global pharmacovigilance need.”

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, including holding a series of meetings with FDA, Health Canada, and the WHO on the subject.

Read more about ASBM’s work with the WHO’s INN Group here. 

April 2021 Newsletter

May 18, 2021

Oklahoma Becomes Final State to Permit Biosimilar Substitution 

 

On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution.

 

SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a substitution, and one may be prevented by the physician if deemed medically necessary.

 

The substitution of medicines is governed at the state level, but state pharmacy acts were written before the advent of biosimilars and did not reflect their differences from generics of small-molecule drugs. Updating these acts nationwide has been a 10-year endeavor involving the collaborative efforts of many patient advocacy organizations, physician and pharmacist societies, manufacturers of originator products and biosimilars, and many other stakeholders.

 

ASBM has worked since 2011 to educate policymakers nationwide by sharing with them the perspectives of the physicians that prescribe biologics, the pharmacists who dispense them, and the patients who receive them.

 

ASBM’s efforts in this decade-long campaign consisted of three nationwide physician surveys, the gathering dozens of patient testimonials, physician and pharmacist interviews, innumerable letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding countless educational forums at colleges of medicine and pharmacy.

 

As ASBM Executive Director Michael Reilly observed:

 

“This 10-year educational campaign spanned the terms of three ASBM Chairmen and touched every single U.S. state and territory. Today marks the end of a long journey- and a fully-realized victory for patients, as the protections of this legislation now reach nationwide.”

 

Read about Oklahoma’s SB4 here.

 

Read about biosimilar substitution laws nationwide here.

 

 
ASBM Presents to World Health Organization at 72nd INN Consultation

 

On April 13th, ASBM presented to the World Health Organization’s (WHO’s) 72nd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the sixteenth 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.

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO.

 

In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 71st INN Consultation – held on October 20, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

 

One argument against distinguishable names was that biosimilars may be seen as inferior and that this would hamper their use. But that has not happened in the USA, and in 5 years of use, two biosimilars of filgrastim have achieved a 72% share of the market; good uptake has also been seen bevacizumab, trastuzumab and pegfilgrastim biosimilars. So, distinguishable names are not an impediment to uptake.

 

Another argument against the BQ is the presence of existing ways of distinguishing biologics, particularly in pharmacovigilance (PV) programmes. Efforts have been made to improve PV programmes through regulation but in a study of the UK adverse drug reaction (ADR) reporting program, no one reporting system is consistently used. Ideally, all methods of identification should be used but in the UK study, only 38% of reports included an identifiable brand name and only 15% had batch numbers. These findings prompted the authors to conclude that the system needs to be improved. These data are consistent with ASBM’s survey findings that show inconsistent information being included in ADR reports with brand name, batch number and the name of the manufacturer not always being specified.

 

As biologics and biosimilars continue to increase, with distinguishable non-proprietary names not having a negative impact on the update of biosimilars, and with PV programmes needing to be improved, the lack of a consistent approach points to a need for WHO leadership, just like is happening for the pandemic.

 

Several early supporters of the BQ have reversed their views, explicitly citing lack of WHO action on naming. Yet they remain willing to harmonise with a global standard should one be made available by the WHO. At the April INN Consultation, the ASBM offered to draft a letter to gauge the level of support for BQ among regulators, and the ASBM repeated this offer

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 
ICYMI: ASBM to Present Poster at DIA Global Annual Meeting 2021

 

From June 27-July 1, 2021, ASBM will virtually present a poster the DIA Global Annual Meeting 2021 entitled “A Review of Problems with Pharmacovigilance Programs and Biologics”. The poster is authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. Dr. Schneider will present the poster in video recording available to conference attendees for the duration of the four-day event.

 

The poster will examine a variety of published literature on global pharmacovigilance of biologic medicines, with a focus on difficulties in accurately identifying biologics at the product level in Adverse Drug Reaction (ADR) reports and self reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.

 

Lack of a consistent international standard for biologic naming was identified as a barrier to biosimilar adoption in a recent WHO-sponsored 20-country study. “There is still no consensus among countries on the naming and labeling of biosimilars,” its authors observed, “and the WHO does not provide specific nomenclature for biosimilars.”

 

In 2014 the WHO’s INN Expert Group proposed a voluntary naming standardto promote accurate biologic identification. But despite early support for the standard from many countries including the US, Canada, Australia, and Japan, it has not yet been made available to national regulatory authorities.

 

DIA 2021 runs from June 27-July 1, 2021. EPosters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2021.

 

Learn more about DIA 2021 and see the draft Program Agenda here. 

 

 
President Biden Signs Biosimilars Education Bill

 

On April 23rd, President Biden signed into law S. 164, the “Advancing Education on Biosimilars Act of 2021,” which authorizes the Food and Drug Administration (FDA) to educate consumers and health care providers on biologic products, including biosimilars.

 

In March, the US Senate unanimously passed the bill, which directs the FDA to improve education on biosimilars with the goal of increasing uptake. Under the law, the FDA will create a biosimilars education website targeted at health care providers. Educational materials offered on the website may include:

  • Explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilars
  • Information related to development programs for biological products, including biosimilars and interchangeable biosimilars, and relevant clinical considerations for prescribers
  • An explanation of the process for reporting adverse events for biological products, including biosimilars and interchangeable biosimilars
  • An explanation of the relationship between biosimilars and interchangeable biosimilars licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product

Comparative data for originator biologics and biosimilars will also be made available; and, on an ongoing basis, the FDA will maintain continuing education programs to inform health care providers, including nurses, about biosimilars.

 

Read more about the Advancing Education on Biosimilars Act (S. 164) here.

 

 

 
UPCOMING EVENTS

 

DIA Global 2021 Annual Meeting

Virtual – June 27- July 1, 2020 

 

WHO 73rd INN Consultation

Geneva, Switzerland – October 19, 2021

 

World Drug Safety Congress

Boston, Massachusetts – October 20-21, 2021

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

ASBM Presents to World Health Organization at 72nd INN Consultation

May 10, 2021

On April 13th, ASBM presented to the World Health Organization’s (WHO’s) 72nd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the sixteenth 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.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO.

In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 71st INN Consultation – held on October 20, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

One argument against distinguishable names was that biosimilars may be seen as inferior and that this would hamper their use. But that has not happened in the USA, and in 5 years of use, two biosimilars of filgrastim have achieved a 72% share of the market; good uptake has also been seen bevacizumab, trastuzumab and pegfilgrastim biosimilars. So, distinguishable names are not an impediment to uptake.

Another argument against the BQ is the presence of existing ways of distinguishing biologics, particularly in pharmacovigilance (PV) programmes. Efforts have been made to improve PV programmes through regulation but in a study of the UK adverse drug reaction (ADR) reporting program, no one reporting system is consistently used. Ideally, all methods of identification should be used but in the UK study, only 38% of reports included an identifiable brand name and only 15% had batch numbers. These findings prompted the authors to conclude that the system needs to be improved. These data are consistent with ASBM’s survey findings that show inconsistent information being included in ADR reports with brand name, batch number and the name of the manufacturer not always being specified.

As biologics and biosimilars continue to increase, with distinguishable non-proprietary names not having a negative impact on the update of biosimilars, and with PV programmes needing to be improved, the lack of a consistent approach points to a need for WHO leadership, just like is happening for the pandemic.

Several early supporters of the BQ have reversed their views, explicitly citing lack of WHO action on naming. Yet they remain willing to harmonise with a global standard should one be made available by the WHO. At the April INN Consultation, the ASBM offered to draft a letter to gauge the level of support for BQ among regulators, and the ASBM repeated this offer

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

Read more about ASBM’s work with the WHO’s INN Group here. 

September 2020 Newsletter

November 10, 2020

Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK)

 

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidance intended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

 

The new guidance is based on current EMA biosimilar guidance, with additional details about:
  • UK reference products
  • the lack of requirement for in vivo studies in animals
  • the changes in the requirement for a comparative efficacy trial in most cases
The consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions.
Comments are being accepted until November 15, 2020. MHRA are hoping to finalise the guidance by the end of the year.
Read the new guidance here.
Submit your comments on the guidance here. 
 

ASBM Chair Madelaine Feldman’s Term Extended

 

ASBM is pleased to announce that effective September 1st, the term of ASBM Chair Madelaine Feldman, MD, FACR, has been extended for an additional year. An ASBM chairman runs for a three-year period. ASBM Executive Director Michael Reilly, offered his praise for Dr. Feldman’s contributions to ASBM during her tenure:
“For the past three years, Dr. Feldman has been a dedicated and tireless advocate for patient-centered policies which increase access to biologic therapies, and keep treatment decisions between their patient and their physicians. Her knowledge and track record of leadership within the patient and physician community have proven invaluable to ASBM’s advocacy efforts, and we look forward to working with her in the upcoming year.”

 

Dr. Feldman began her term in September of 2017 and is ASBM’s third chairman since it was establishment in late 2010. ASBM’s inaugural chair Richard Dolinar, MD, served from 2011-2014 and was succeeded by Harry Gewanter, MD, MACR, who served from 2014-2017.

 

 
ASBM Presents Poster at Biologics World Nordic 2020
On September 30th, ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, presented virtually at the 3rd Annual Biologics World Nordic conference. Biologics World Nordic 2020 is the only conference in the Nordic region focused on biologic drugs and vaccines.

 

Mr. Spiegel’s video presentation consisted of three sections: patient perspectives on biosimilars, biosimilar substitution practices in Europe, and  physician perspectives on substitution:

 

First, he described the patient perspective on biologic medicines:
The patient community is excited about biosimilars. We’ve gone from one drug for colorectal cancer (CRC) to over a dozen in less than two decades; half of these are biologics. During that time, the life expectancy of late stage CRC patients has gone from months to years.This means more time with their families- meeting their grandchildren and attending the weddings of their children.

 

“Biosimilars offer many benefits to patients”, Spiegel explained, “including increased access to biologic therapies, and lower costs. As countries develop policies around biosimilars”, he continued, “we want to make sure these policies work for patients.”

 

One area of patient concern he identified is non-medical switching– where a patient is switched by private or government payers for reasons other than the patients health or safety- typically for cost reasons. “This has the potential to lessen the control a patient has over his or her condition, and most physicians do not support doing this,” he observed.

 

Spiegel supported this assertion with a poster based on data from ASBM’s 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. For example, 73% percent of those surveyed stated they were uncomfortable with a third-party intiated switch made for non-medical reasons.

 

While permitted in a handful of countries (including the conference’s host country of Denmark), the automatic substitution of biologic medicines is extremely rare in Europe, observed Spiegel:

 

In nearly every European country, physicians and their patients are free to choose between a number of different biologics, and all the products are reimbursed. This competition drives down costs, and savings for the health system are achieved that way rather than through forced substitution.

 

View Mr. Spiegel’s video presentation here.

 

View or download the poster here. 

 

 
ASBM European Survey Published in Fall 2020 GaBI Journal

This month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published Issue 3 of its 2020 print edition. This issue contains a whitepaper by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR; entitled “European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution”. The paper explores in detail the findings of ASBM’s survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries.

Topics examined include physician perspectives on prescribing biosimilars, physician-led biosimilar substitution vs. third-party substitution, adverse event reporting, and design of government tenders.

 

As detailed in the paper, European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so too has the importance to them of maintaining control of treatment decisions:

  • 82% consider maintaining physician control of treatment decisions to be very important or critical, representing a 10% increase from the 2013 survey.
  • Physicians are also highly uncomfortable with a non-medical substitution initiated by a third party. This figure too has increased sharply since the 2013 survey: 73% are uncomfortable with this, compared to 58% in 2013.
  • A strong majority (63%) consider it highly important for governments to make multiple therapeutic choices available in tenders, and a very strong majority (83%) believe these tenders should take into account factors besides price.

Read the full whitepaper online here.
View a poster based on the findings here. 

 

 
ASBM Campaign Educates on Non-Medical Switching in Canada, Contrasts with European Approach.  
Throughout September, ASBM ran an extensive social media campaign on the topic of non-medical switching and forced biosimilar substitution, aimed at educating stakeholders in Canada about the practice with informative graphics and and supporting materials. These resources were made available both in English and in French.

British Columbia and Alberta have recently implemented, or begun implementing forced biosimilar switching policies,and other provinces are considering following suit. The controversial policy has drawn criticism from Canadian patient advocacy organizations including the Gastrointestinal Society, as well as the Canadian Association of Gastroenterology.

 

The British Columbia- and Alberta- style substitution policy stands in stark contrast to the approach taken by nearly every European country. The European approach is explored in great detail in the recent whitepaper published in GaBI Journal, “Policy recommendations for a sustainable biosimilars market: lessons from Europe”. The vast majority of European countries preserve physician/patient control of treatment decisions, reimburse multiple products, and control costs through competition rather than through forced substitution.
The campaign also highlights the strong opposition among European physicians to third-party substitution for non-medical reasons. (Notably, these sentiments are highly consistent with those of their Canadian counterparts, as revealed in ASBM’s 2017 survey of 403 Canadian physicians.)

 

Below are several ads used in the campaign. These are aimed at patients, physicans, and policymakers in Alberta, Ontario, and Quebec.

 

Ad —English patient groups
Ad —English health care practitioners
Ad —Ontario government decision-makers
Ad —French patient groups
Ad—French health care practitioners
Ad —French QC decision-makers
Ad —New Ontario government decision-makers
Click here to learn more about Biosimilar Substitution in Canada. 

 

Download the factsheet “Biosimilar Substitution: What Can Canada Learn from the European Experience?” 

 

Read the ASBM whitepaper on the European biosimilar markets.

 

 

 
ASBM’S Schneider Chairs Pharmacovigilance Panel at World Drug Safety Congress USA 2020

 

On September 2nd, ASBM Advisory Board Chair Dr. Philip Schneider chaired a virtual panel discussion session on pharmacovigilance and distinct naming at the World Drug Safety Congress USA 2020. The program’s title was “Biosimilar risk assessment and pharmacovigilance.”

 

A key topic of the discussion was the greater emphasis on analytics in biosimilar approvals and decreasing emphasis on clinical trials. Biosimilars can also be approved, via extrapolation, for indications of the reference product for which they have undergone no clinical trials.

 

For this reason, the panelists were in agreement that post-marketing surveillance and the gathering of real-world data was important to biosimilar pharamcovigilance. They also agreed that ensuring accurate identification of biologics, including correct attribution of adverse events, was critical to these efforts.

 

Among the panelists was Dr. Raffaella Balocco, leader of the World Health Organization’s Expert Group on International Nonproprietary Names (INN). Following years of study on how to improve pharmacovigilance for biologic and biosimilar medicines, the INN Group offered its recommendation: the Biologic Qualifier (BQ).

 

The BQ is a four-letter suffix that would be appended to an INN shared by an originator biologic and all biosimilars. It would be a voluntary standard made available by the WHO to countries. Despite early and broad support from a number of countries, including the U.S., Canada, and Australia, the recommendation has not yet implemented by the WHO. The BQ was influential, however, on the development of the FDA’s four-letter suffix system, implemented in 2015.

 

Read more about the World Drug Safety Congress here. 

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

 
UPCOMING EVENTS

 

DIA Annual Canadian Meeting

Virtual – October 19-20, 2020

 

WHO 71st Consultation on International Nonproprietary Names

Geneva, Switzerland – October 20-23, 2020

 

World Biosimilar Congress Europe 2020

Virtual – November 3-5, 2020

 

ACR Convergence 2020

Virtual – November 6-11, 2020

October 2020

November 5, 2020

ASBM Launches New Microsite on Forced Switching in Canada
On October 28th, ASBM launched a new microsite focused on the issue of forced biosimilar substitution in Canada- the forcing of patients off their physician-prescribed biologics and onto preferred government-chosen products.

 

www.NoForcedSwitching.ca

 

This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.

 

The microsite contains a variety of materials, including:

  • National and province-specific news stories about how provinces have implemented, or are considering such policies.
  • Statements from physician societies and patient advocacy organizations raising concerns with the practice
  • Fact sheets contrasting the forced-substitution policies of British Columbia and Alberta with the pro-competition policies of European countries
  • Surveys showing strong physician opposition to third-party non-medical substitutions from physicians in Europe and Canada
  • A whitepaper showing how European countries achieve biosimilar savings by preserving- not limiting- physician and patient choice
  • Shareable social media graphics
  • The ability for Canadians to quickly send a message to your Health Minister expressing your opposition to forced substitution in their province

 

We encourage you to take a moment to visit: www.noforcedswitching.ca

 

 
Reminder: Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK) Closes November 15th

 

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

 

The new guidance is based on current EMA biosimilar guidance, with additional details about:
  • UK reference products
  • the lack of requirement for in vivo studies in animals
  • the changes in the requirement for a comparative efficacy trial in most cases
The consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions.
Comments are being accepted until November 15, 2020. MHRA are hoping to finalise the guidance by the end of the year.
Read the new guidance here.
Submit your comments on the guidance here. 
 

Public Webinar on Final PMPRB Guidelines November 20th

 

Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).

 

ASBM and the Gastrointestinal Society jointly submitted formal comments on the PMPRB draft guidelines during the stakeholder consultation. From the comments:

 

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.

 

Originally scheduled to take effect on July 1, earlier this summer the implementation of the changes was delayed until 2021.

 

The link for the webinar can be accessed from the PMPRB’s  Guidelines Home Page. No registration is required to join the webinar.

 

 

 
ASBM Whitepaper on US Biosimilar Market to be Published in Winter 2020 GaBI Journal

Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.

The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:

 

In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

 

The paper may be viewed online at Gabi’s website here.  

 

 

 
Reminder: National Policy & Advocacy Virtual Summit on Biologics November 18

 

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.

 

The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.

 

Click here to register for the event.

 

 
 

ASBM Presents at WHO’s 71st INN Consultation 

 

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings 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.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA. The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own system but would have used a WHO system if WHO had moved ahead with the BQ.

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

 
UPCOMING EVENTS

 

DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
Virtual – Nov 11-12, 2020

 

National Policy & Advocacy Virtual Summit on Biologics

Virtual – November 18, 2020

 

Saudi Gastroenterology Association Conference

Virtual – November 22, 29, 2020

 

 

October 2020

November 5, 2020

ASBM Launches New Microsite on Forced Switching in Canada
On October 28th, ASBM launched a new microsite focused on the issue of forced biosimilar substitution in Canada- the forcing of patients off their physician-prescribed biologics and onto preferred government-chosen products.

 

www.NoForcedSwitching.ca

 

This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.

 

The microsite contains a variety of materials, including:

  • National and province-specific news stories about how provinces have implemented, or are considering such policies.
  • Statements from physician societies and patient advocacy organizations raising concerns with the practice
  • Fact sheets contrasting the forced-substitution policies of British Columbia and Alberta with the pro-competition policies of European countries
  • Surveys showing strong physician opposition to third-party non-medical substitutions from physicians in Europe and Canada
  • A whitepaper showing how European countries achieve biosimilar savings by preserving- not limiting- physician and patient choice
  • Shareable social media graphics
  • The ability for Canadians to quickly send a message to your Health Minister expressing your opposition to forced substitution in their province

 

We encourage you to take a moment to visit: www.noforcedswitching.ca

 

 
Reminder: Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK) Closes November 15th

 

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

 

The new guidance is based on current EMA biosimilar guidance, with additional details about:
  • UK reference products
  • the lack of requirement for in vivo studies in animals
  • the changes in the requirement for a comparative efficacy trial in most cases
The consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions.
Comments are being accepted until November 15, 2020. MHRA are hoping to finalise the guidance by the end of the year.
Read the new guidance here.
Submit your comments on the guidance here. 
 

Public Webinar on Final PMPRB Guidelines November 20th

 

Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).

 

ASBM and the Gastrointestinal Society jointly submitted formal comments on the PMPRB draft guidelines during the stakeholder consultation. From the comments:

 

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.

 

Originally scheduled to take effect on July 1, earlier this summer the implementation of the changes was delayed until 2021.

 

The link for the webinar can be accessed from the PMPRB’s  Guidelines Home Page. No registration is required to join the webinar.

 

 

 
ASBM Whitepaper on US Biosimilar Market to be Published in Winter 2020 GaBI Journal

Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.

The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:

 

In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

 

The paper may be viewed online at Gabi’s website here.  

 

 

 
Reminder: National Policy & Advocacy Virtual Summit on Biologics November 18

 

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.

 

The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.

 

Click here to register for the event.

 

 
 

ASBM Presents at WHO’s 71st INN Consultation 

 

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings 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.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA. The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own system but would have used a WHO system if WHO had moved ahead with the BQ.

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

 
UPCOMING EVENTS

 

DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
Virtual – Nov 11-12, 2020

 

National Policy & Advocacy Virtual Summit on Biologics

Virtual – November 18, 2020

 

Saudi Gastroenterology Association Conference

Virtual – November 22, 29, 2020

 

 

ASBM Presents at WHO’s 71st INN Consultation 

October 30, 2020

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings 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.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA. The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own system but would have used a WHO system if WHO had moved ahead with the BQ.

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

ASBM Presents at WHO’s 71st INN Consultation 

October 30, 2020

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings 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.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA. The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own system but would have used a WHO system if WHO had moved ahead with the BQ.

 

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

July-August 2020 Newsletter

September 6, 2020

GaBI Publishes ASBM Whitepaper on European Physician Survey

On August 28th, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a whitepaper entitled “European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution”. The paper explores in detail the findings of ASBM’s survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries.

Topics examined include physician perspectives on prescribing biosimilars, physician-led biosimilar substitution vs. third-party substitution, adverse event reporting, and design of government tenders.

 

As detailed in the paper, European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so too has the importance to them of maintaining control of treatment decisions:

  • 82% consider maintaining physician control of treatment decisions to be very important or critical, representing a 10% increase from the 2013 survey.
  • Physicians are also highly uncomfortable with a non-medical substitution initiated by a third party. This figure too has increased sharply since the 2013 survey: 73% are uncomfortable with this, compared to 58% in 2013.
  • A strong majority (63%) consider it highly important for governments to make multiple therapeutic choices available in tenders, and a very strong majority (83%) believe these tenders should take into account factors besides price.

The paper will be also published in Issue 3 of the GabI Journal’s 2020 print edition this fall. 
Read the full whitepaper online here.

 

 
Study: Biosimilar Infliximab Uptake Slow, But Tracks With Europe

 

The uptake of infliximab biosimilars in the United States is slow but tracks closely to the experience in Europe, according to a new study. After 2 years, infliximab biosimilars assumed a large share of the Europe market. While biosimilar filgrastim has gained large market share in the U.S., uptake of biosimilar infliximab has lagged that of biosimilar filgrastim.

 

As the Center for Biosimilars reported August 5th:

 

The study authors said the reasons for the slower adoption of infliximab biosimilars compared with the previous filgrastim biosimilar are unknown. However, they speculated that ‘patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one.

However, they acknowledged that “a considerable minority of patients did switch between biologic and biosimilar versions in 2018,” and suggested switching could have been the result of cost reductions, such as lower patient co-pays or physician rebates.

 

Read more about the study here.

 

 
Two New Biosimilars Launch in Canada

 

The month of August saw two new biosimilars launch in Canada:

 

The first, Ziextenzo, is a biosimilar pegfilgrastim- a long-acting form of recombinant human granulocyte colony-stimulating factor (r-metHuG-CSF), or filgrastim. It is was approved April 21st of this year by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents. Neutropenia is one of the most serious side effects of chemotherapy.

 

The second, Riximyo, is a biosimilar to rituximab, a monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as the rheumatoid arthritis (RA). It was approved by Health Canada on April 28th of this year.

Read more about the approvals here. 

 
ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List 

 

On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to July 30th.)

When the comment period was initially announced, several biologic medicines had been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings. These included the biologics trastuzumab and bevacizumab, widely used in cancer treatment.

 

Thankfully, when extending the deadline for comments, NIOSH indicated that trastuzumab and bevacizumab were no longer being considered for inclusion on the List.

ASBM’s previous comments regarding the inclusion of monoclonal antibodies on the NIOSH list were among those cited in the Federal Register as the reason for the change:

 

Comment: Monoclonal antibodies (i.e., therapeutic proteins) are of such a large molecular weight that they do not pose a realistic risk to healthcare workers. For example, monoclonal antibodies ‘‘are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. Consequently, these drugs are all administered by injection. The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose.’’

Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from [Table 1].

 

In ASBM’s comments, executive director Michael Reilly and Philip Schneider commended NIOSH for these revisions to the list:

 

The placement of these medicines on the NIOSH List would have compelled healthcare workers to take extraordinary precautions when handling and dispensing these drugs- including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter <800>.

 

This would have imposed a significant burden on health care providers, imposing requirements for safe receipt, storage, preparation, and administration. These burdens would have increased health care costs unnecessarily and negatively affected access to these new, breakthrough therapies; such as by limiting which sites these critical medications are available and can be administered, such as infusion clinics and a physician’s office setting.

 

ASBM recognizes that balancing health care worker safety against health care cost impact and patient access is a complicated consideration in policy development, and we trust that NIOSH will continue to make good decisions as it attempts to strike the proper balance during its deliberations.

 

More information about the Proposed List of Hazardous Drugs may be found here. 

 

Read ASBM’s full comments here. 

 
 

Biosimilar Working Group Sends Letter to Quebec Health Minister, Urging Rejection of Forced-Substitution Policies

 

In a letter dated July 29th, the Canada-based Biosimilars Working Group (of which ASBM is a member) urged Quebec Health Minister Christian Dubé, MLA to reject forced biosimilar substitution policies embraced by some Canadian provinces. The group also asked Minister Dubé to gather input from the patient community before adopting a biosimilar substitution policy. From the letter:

 

In your upcoming deliberations, we request full consultations with patient groups before you reach any conclusions. This way, policy can be forged in a manner that keeps Canadians safe, especially during this current pandemic and beyond. There can be no one-size-fits-all approach and developing policy with fulsome input from those who will be directly impacted will help achieve the desired outcomes effectively.

 

We thank you for the recent report from INESSS, which concluded that there are certain populations who are taking biologics for which very little or no data are available regarding the safety of switching to biosimilars, and identifies significant concerns that clinicians have about non-medical switching. As patient groups, we share their concerns.

 

Read the full letter here. 

 
 

Report: Canada’s Pharmaceutical Pricing Reforms Creating Negative Impacts for Patients

A sweeping and controversial reform of Canada’s 30-year old regime overseeing patented medicine prices is already creating negative impacts in the life sciences sector and reducing patients’ access to medicines, according to a new report from Innovative Medicines Canada and Life Sciences Ontario.

The regulations, drafted by Canada’s Patented Medicine Prices Review Board (PMPRB) were published in Canada Gazette2 (CG2) in August 2019, signs of its negative impact are already becoming apparent. Among its findings:

  • Many therapeutic areas will be impacted by the new PMPRB regulations: These include oncology, biologics, rare disorders, immunology, gene/cell therapy, rheumatology, and other areas; according to a survey of pharmaceutical executives.
  • New drug submissions are down: In the 9 months following CG2, there was a decline in timely submissions made in Canada to 24% of global submissions, compared to 35-40% in the 3 previous 12-month periods.
  • New drug launches are increasingly delayed: In the 9 months following CG2, delayed or cancelled launches doubled to 42% of approvals, compared to the 3 previous 12-month periods.
  • Clinical drug trials are down: As of early June 2020, Informa data suggest that there was a decline in the share of global industry-funded clinical trials that were started in Canada in the 9 months following CG2 down to 9.2% from 10.5% in the 3 previous 12-month periods.
  • Patient advocacy organizations are opposed to the PMPRB changes: representatives from the 30-group Best Medicines Coalition, the CF Treatment Society, the Sickle Cell Disease Association, and others have registered their strong opposition to the changes. According to the Canadian Organization for Rare Disorders:

“The Canadian government and particularly Health Canada have completely forgotten about the people it should be serving and helping: Canadian patients. There will be delayed access or, worse, no access to new medicines as a result of these changes, and this will harm patients.”

 

The report combines data from an opinion survey of pharmaceutical manufacturers with objective metrics on clinical trials, new drug submissions and launches obtained from publicly-available government and commercial databases such as Informa Citeline, Health Canada’s NOC, Drug Product and Drug and Health Product Submissions Under Review databases, and EMA and FDA databases.

 

Read the full report here. 
 

 

FDA Approves 28th Biosimilar, Sixth for Adalimumab

 

On July 6th, the FDA approved its 28th biosimilar, HULIO (adalimumab-fkjp).

The approval also represents the sixth biosimilar approved by the FDA for adalimumab (HUMIRA). The first was AMJEVITA (adalimumab-atto), approved in September 2016, and the most recent was ABRILADA (adalimumab-afzb), approved in December of 2019.

Like its reference product, HUMIRA (adalimumab), HULIO is approved a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

As of yet, no adalimumab biosimilars have launched in the U.S. due to HUMIRA’s patent protection, which is set to expire in 2023.

Read more about the approval here. 
 

GaBI Journal: UK Study Shows Need for Improved Identification of Biologics

An article in the summer issue of the Journal of the Generics and BIosimilars Initiative (GaBI Journal) emphasizes the need for improved pharmacovigilance with biologic medicines in the UK.

The article, entitled “Poor traceability of biologicals in UK ADR reporting indicates the need for improvements to ensure patient safety” covers the UK BIO-TRAC study, which conducted an online survey of hospital pharmacists and analysed total of 6,108 electronic Adverse Drug Reaction (ADR) reports in order to assess the effectiveness of pharmacovigilance legislation enacted in 2012 to strengthen product identification. As the study authors explain,
Due to their complex structures and the inherent challenges for manufacturing, a degree of minor variability may exist between different batches of the same product and between original biological and follow-on versions, so-called biosimilars. Thus, when adverse drug reactions (ADRs) occur, it is important to know the precise brand name and batch number of the biological involved.

Several studies have concluded, however, that specific product details are not always provided in ADR reports. Consequently, the aim of this study (UK BIO-TRAC study) was to assess the extent to which biologicals are traceable by brand name and batch number in UK hospital practice and in reports of ADRs submitted by patients and healthcare professionals.

The study revealed that brand name recording in routine hospital processes ranged from 79% to 91%, whereas batch numbers were less routinely recorded, ranging from 38% to 58%. Among the ADR reports analyzed, only 38% had an identifiable brand name and 15%, batch numbers. (Note: this is consistent with ASBM’s 2019 survey of UK physicians, which revealed that only 30% consistently include the batch number in ADR reports and 18% rarely or never include them.) 

As the authors conclude, “Whereas batch number traceability in electronic ADR reports improved slightly after the implementation of the European Union pharmacovigilance legislation in 2012, no improvement of brand name traceability was observed in the UK.”

Yet as ASBM noted in its April 2020 presentation at the World Health Organization’s 70th Consultation on International Nonproprietary Names, fully 35% of adverse event reports submitted in the EU for infliximab products in 2018 did not specify a brand name, according to EudraVigilance, the EMA’s database of suspected adverse drug reaction reports.

In order to ensure the accurate identification of all biologic medicines, in 2014 the INN Expert Group recommended the WHO implement the Biologic Qualifier (BQ) proposal – a voluntary standard which affixes distinct four-letter suffixes to the names of biologics which share a nonproprietary name. Despite early support from many countries including the U.S., Canada, Australia, Japan, and others the BQ proposal remains unimplemented. The FDA has since adopted its own BQ-like suffix system.

The article appears in GaBI Journal Volume 9, Year 2020, Issue 2, and may also be read online here.

Read the abstract of the UK BIO-TRAC study here.

Learn more about ASBM’s work to advance the distinct naming of biologics globally here.

 
Alberta MP To Provide Feedback to Government on Drug Pricing Guidelines Following Implementation Delay

 

Alberta’s Shadow Health Minister, Matt Jeneroux, has used a recent implementation delay for new drug pricing guidelines from the Patented Medicines Pricing Review Board (PMPRB) to collect additional feedback about the proposed changes and will be presenting a comprehensive report to the government in the fall based on his findings.

 

Originally scheduled to take effect on July 1, earlier this summer the implementation was delayed until 2021, in order for the PMPRB to make “significant changes” in response to feedback it received during a public consultation period.
ASBM and the Gastrointestinal Society jointly submitted formal comments on the PMPRB draft guidelines during the stakeholder consultation. From the comments:

 

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.
“I’m relieved that the voices of patients have been heard and the government has decided to delay the changes,” said Matt Jeneroux, a Member of Alberta’s Parliament representing Edmonton-Riverbend.  “However, we still have a lot of uncertainty and I expect the government to use this additional time to better consult with patients. We could see a drug shortage if these changes go ahead as planned in six months. Canada will no longer be a competitive marketplace and drug companies will be reluctant to bring their therapies here.”
Read ASBM’s and the Gastrointestinal Society’s February comments in their entirety here. 
UPCOMING EVENTS

 

DIA Annual Canadian Meeting

Virtual – October 19-20, 2020

 

WHO 71st Consultation on International Nonproprietary Names

Geneva, Switzerland – October 20-23, 2020

 

World Biosimilar Congress Europe 2020

Virtual – November 3-5, 2020

 

ACR Convergence 2020

Virtual – November 6-11, 2020

 

 

GaBI Journal: UK Study Shows Need for Improved Identification of Biologics

August 30, 2020

An article in the summer issue of the Journal of the Generics and BIosimilars Initiative (GaBI Journal) emphasizes the need for improved pharmacovigilance with biologic medicines in the UK.

The article, entitled “Poor traceability of biologicals in UK ADR reporting indicates the need for improvements to ensure patient safety” covers the UK BIO-TRAC study, which conducted an online survey of hospital pharmacists and analysed total of 6,108 electronic Adverse Drug Reaction (ADR) reports in order to assess the effectiveness of pharmacovigilance legislation enacted in 2012 to strengthen product identification. As the study authors explain,

Due to their complex structures and the inherent challenges for manufacturing, a degree of minor variability may exist between different batches of the same product and between original biological and follow-on versions, so-called biosimilars. Thus, when adverse drug reactions (ADRs) occur, it is important to know the precise brand name and batch number of the biological involved.

Several studies have concluded, however, that specific product details are not always provided in ADR reports. Consequently, the aim of this study (UK BIO-TRAC study) was to assess the extent to which biologicals are traceable by brand name and batch number in UK hospital practice and in reports of ADRs submitted by patients and healthcare professionals.

The study revealed that brand name recording in routine hospital processes ranged from 79% to 91%, whereas batch numbers were less routinely recorded, ranging from 38% to 58%. Among the ADR reports analyzed, only 38% had an identifiable brand name and 15%, batch numbers. (Note: this is consistent with ASBM’s 2019 survey of UK physicians, which revealed that only 30% consistently include the batch number in ADR reports and 18% rarely or never include them.) 

As the authors conclude, “Whereas batch number traceability in electronic ADR reports improved slightly after the implementation of the European Union pharmacovigilance legislation in 2012, no improvement of brand name traceability was observed in the UK.”

Yet as ASBM noted in its April 2020 presentation at the World Health Organization’s 70th Consultation on International Nonproprietary Names, fully 35% of adverse event reports submitted in the EU for infliximab products in 2018 did not specify a brand name, according to EudraVigilance, the EMA’s database of suspected adverse drug reaction reports.

In order to ensure the accurate identification of all biologic medicines, in 2014 the INN Expert Group recommended the WHO implement the Biologic Qualifier (BQ) proposal – a voluntary standard which affixes distinct four-letter suffixes to the names of biologics which share a nonproprietary name. Despite early support from many countries including the U.S., Canada, Australia, Japan, and others the BQ proposal remains unimplemented. The FDA has since adopted its own BQ-like suffix system.

The article appears in GaBI Journal Volume 9, Year 2020, Issue 2, and may also be read online here.

Read the abstract of the UK BIO-TRAC study here.

Learn more about ASBM’s work to advance the distinct naming of biologics globally here.