ASBM Letter Opposes BIll That Would Undermine Physician-Patient Relationship

December 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

On December 2nd, ASBM sent a letter to House leaders reiterating our opposition. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:

 

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally. 

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

Read ASBM’s full letter here.
Read the current text of H.R. 5376 here.

ASBM Letter Opposes BIll That Would Undermine Physician-Patient Relationship

December 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

On December 2nd, ASBM sent a letter to House leaders reiterating our opposition. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:

 

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally. 

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

Read ASBM’s full letter here.
Read the current text of H.R. 5376 here.

ASBM’s Madelaine Feldman Testifies at House Oversight Committee

December 2, 2021

On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony:

The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…

High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

Read more about the Oversight Committee hearing here.

Read Dr. Feldman’s full testimony here. 

ASBM’s Madelaine Feldman Testifies at House Oversight Committee

December 2, 2021

On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony:

The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…

High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

Read more about the Oversight Committee hearing here.

Read Dr. Feldman’s full testimony here. 

ASBM Presents at World Biosimilar Congress Europe

November 15, 2021

From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, 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 (GCCA).

The theme of the three-day meeting was “Celebrating 15 years of Biosimilars in Europe.”  Professor Schneider chaired the Keynote Panel Discussion titled “Regulatory lessons learned from the past 15 years and what can regulatory guidelines do to improve access going forward.”
baselpanel3
Members of the panel included a representatives from the European Medicines (EMA) and drug manufacturers. The perspective that emerged in this discussion is that the issue of interchangeability of biosimilars in becoming less important in the EU and the need for clinical trials for market authorization of biosimilars is decline. It was also agreed that physician and patient involvement in developing regulatory guidelines is important and strong pharmacovigilance programs are essential.
baselpanel2
There were several sessions on the topic of sustainability that addressed the need for balance in the efforts to contain costs while maintaining a competitive marketplace by increasing the number of biosimilars and creating new reference products.  Schneider chaired the sessions on this topic, gave a presentation titled “Problems with Pharmacovigilance Programs: an Opportunity for Improvement,” and chaired a panel discussion “Creating a sustainable future for biosimilars.” Topics discussed in the panel included the need to included factors other than price such as drug administration devices and supply chain reliability in tender decisions and the pros and cons of gain-sharing programs that are intended to create the incentive to use biosimilars in the clinical setting.
baselpanel
Andrew Spiegel chaired a 3-hour session on Biosimilars in Oncology – which involved introducing the speakers and their presentation topics. He also hosted his own Roundtable on Biosimilars in Oncology, at which the topic of forced biosimilar switching was discussed. The oncologists present expressed their strong opposition to the practice.
Spiegel also hosted two Fireside Chats during the meeting.
img_2544The first was with Antonella Cardone, executive director of the European Cancer Patient Coalition. Its theme was ‘The Importance of Biosimilars in Oncology” and featured patient survey data. “The European patient community mostly in alignment with ASBM members on opposing forced switching and preferring to make treatment decisions with their physicians, said Mr. Spiegel.
img_2542
The second Fireside Chat was with a representative from a biosimilar manufacturer, Sundar Ramanan, entitled ‘Promoting Equitable Access of Biosimilars Across Therapeutic Areas.”

Read more about the World Biosimilar Congress 2021 Europe here. 

October 2021 Newsletter

November 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

 

The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

 

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

 

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

 

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. In July, ASBM sent a letter to Congress opposing this proposal’s inclusion in H.R. 2815. From the letter:

 

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally. 

 

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

 

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

 

 

Read ASBM’s full letter here.
Read the current text of H.R. 5376 here.

 

 

 
Ohio State University College of Pharmacy To Launch Online CE Program

 

In the coming weeks, the Ohio State University College of Pharmacy will launch a new online Continuing Education (CE) program. Among the first offerings in this program will be a series of presentations related to biologics and biosimilars, sponsored by ASBM. Topics will include a primer on biologics and biosimilars, substitution of biologics and biosimilars, issues with non-medical switching, pharmacovigilance programs and the importance of distinguishable non-proprietary names, the biosimilars market, physician perspectives on biologics and biosimilars, and patient perspectives.

 

The new CE platform being used at OSU will be available nationwide. With the rapid increase in the number of biologic and biosimilars reaching the market and the advent of interchangeable biosimilars, the need for educational programming for pharmacists is significant.

 

This program will equip pharmacists with the knowledge needed to play an important role in helping to navigate the increasingly complex challenges associated with the safe and effective use of biologics and the responsible use of limited healthcare resources.

 

 
ASBM Presents at World Drug Safety Congress USA 2021

 

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

 

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

 

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics 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.

 

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

 

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.

 

 
ASBM Presents at WHO’s 73rd INN Consultation

 

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. 

 

 

 
Michael Reilly Op-ed: Forced Biosimilar Switching Would Put Ontario on Wrong Track

 

On October 5, an op-ed by ASBM Executive Director Michael Reilly ran in several Ontario papers including The Hamilton Spectator, the Welland Tribune, the St. Catharine’s Standard, and the Niagara Falls Review.

 

The op-ed highlights the concerns with forced-biosimilar-substitution policies

 

A survey of 403 Canadian specialists found that 73% are uncomfortable with a third party initiating a biologic switch for non-medical reasons (typically the cost), as occurs in the British Columbia and Alberta policies. These findings were affirmed by Quebec’s own government (INESSS) in a May 2020 report which concluded that “Non-medical switching in patients being treated with a reference biologic is generally not accepted by learned societies and the consulted clinicians.”

 

The Canadian Association of Gastroenterology (CAG) released a paper objecting to the B.C. policy; noting that BC Pharmacare’s substitution policy went against the recommendations of 14 gastroenterology societies throughout Canada and Europe. Many patient advocacy organizations also opposed these policies, including the Gastrointestinal Society and Crohn’s and Colitis Canada.

 

“It was a very long, difficult 2 1/2 year journey to find [the originally-prescribed] drug. All other drugs failed,” said one B.C. arthritis patient who was forced to switch. “I am shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs.”

 

The New Brunswick and Quebec announcements cited 15 years of experience with biosimilars in Europe to justify forced switching. However, as the op-ed explains:

 

Automatic substitution of biologics is almost universally prohibited in Europe. In nearly every European country, physicians are free to choose between multiple products, including the originators, and the payer will reimburse them – resulting in both high biosimilar usage and high savings while preserving patient and physician control of treatment decisions.

 

Mr. Reilly recently authored similar op-eds in New Brunswick (English) and Quebec (French).

 

 

Read ASBM’s recent whitepaper “A Critical Review of Substitution Policy for Biosimilars in Canada.” The paper contrasts the forced-substitution policies of some Canadian provinces with the competition-based approaches which have driven biosimilar uptake in Europe and the U.S. 

 

 
FDA Finalizes Guidance on Biosimilar Development

 

In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

 

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

 

Learn more about the updated guidance here. 

 

Read the guidance here. 

 
UPCOMING ASBM EVENTS

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

 

 

 

October 2021 Newsletter

November 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

 

The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

 

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

 

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

 

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. In July, ASBM sent a letter to Congress opposing this proposal’s inclusion in H.R. 2815. From the letter:

 

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally. 

 

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

 

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

 

 

Read ASBM’s full letter here.
Read the current text of H.R. 5376 here.

 

 

 
Ohio State University College of Pharmacy To Launch Online CE Program

 

In the coming weeks, the Ohio State University College of Pharmacy will launch a new online Continuing Education (CE) program. Among the first offerings in this program will be a series of presentations related to biologics and biosimilars, sponsored by ASBM. Topics will include a primer on biologics and biosimilars, substitution of biologics and biosimilars, issues with non-medical switching, pharmacovigilance programs and the importance of distinguishable non-proprietary names, the biosimilars market, physician perspectives on biologics and biosimilars, and patient perspectives.

 

The new CE platform being used at OSU will be available nationwide. With the rapid increase in the number of biologic and biosimilars reaching the market and the advent of interchangeable biosimilars, the need for educational programming for pharmacists is significant.

 

This program will equip pharmacists with the knowledge needed to play an important role in helping to navigate the increasingly complex challenges associated with the safe and effective use of biologics and the responsible use of limited healthcare resources.

 

 
ASBM Presents at World Drug Safety Congress USA 2021

 

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

 

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

 

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics 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.

 

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

 

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.

 

 
ASBM Presents at WHO’s 73rd INN Consultation

 

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. 

 

 

 
Michael Reilly Op-ed: Forced Biosimilar Switching Would Put Ontario on Wrong Track

 

On October 5, an op-ed by ASBM Executive Director Michael Reilly ran in several Ontario papers including The Hamilton Spectator, the Welland Tribune, the St. Catharine’s Standard, and the Niagara Falls Review.

 

The op-ed highlights the concerns with forced-biosimilar-substitution policies

 

A survey of 403 Canadian specialists found that 73% are uncomfortable with a third party initiating a biologic switch for non-medical reasons (typically the cost), as occurs in the British Columbia and Alberta policies. These findings were affirmed by Quebec’s own government (INESSS) in a May 2020 report which concluded that “Non-medical switching in patients being treated with a reference biologic is generally not accepted by learned societies and the consulted clinicians.”

 

The Canadian Association of Gastroenterology (CAG) released a paper objecting to the B.C. policy; noting that BC Pharmacare’s substitution policy went against the recommendations of 14 gastroenterology societies throughout Canada and Europe. Many patient advocacy organizations also opposed these policies, including the Gastrointestinal Society and Crohn’s and Colitis Canada.

 

“It was a very long, difficult 2 1/2 year journey to find [the originally-prescribed] drug. All other drugs failed,” said one B.C. arthritis patient who was forced to switch. “I am shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs.”

 

The New Brunswick and Quebec announcements cited 15 years of experience with biosimilars in Europe to justify forced switching. However, as the op-ed explains:

 

Automatic substitution of biologics is almost universally prohibited in Europe. In nearly every European country, physicians are free to choose between multiple products, including the originators, and the payer will reimburse them – resulting in both high biosimilar usage and high savings while preserving patient and physician control of treatment decisions.

 

Mr. Reilly recently authored similar op-eds in New Brunswick (English) and Quebec (French).

 

 

Read ASBM’s recent whitepaper “A Critical Review of Substitution Policy for Biosimilars in Canada.” The paper contrasts the forced-substitution policies of some Canadian provinces with the competition-based approaches which have driven biosimilar uptake in Europe and the U.S. 

 

 
FDA Finalizes Guidance on Biosimilar Development

 

In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

 

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

 

Learn more about the updated guidance here. 

 

Read the guidance here. 

 
UPCOMING ASBM EVENTS

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

 

 

 

ASBM Presents at World Drug Safety Congress USA 2021

November 8, 2021

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics 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.

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.

 

FDA Finalizes Guidance on Biosimilar Development

November 2, 2021

In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

Learn more about the updated guidance here. 

Read the guidance here. 

Help Celebrate the First National Biologic Coordinator’s Day

November 1, 2021

nbcd_logo_darkbluebackground_finalToday, November 1st, is the First National Biologic Coordinator’s Day. 

Starting and staying on a prescribed biologic treatment can be a complex process for patients—but it doesn’t always have to be. Thanks to the tireless work of BIOLOGIC COORDINATORS, patients are able to access their prescribed biologic treatments.

A biologic coordinator is a key member of a medical practice’s office staff–a doctor, nurse, physician’s assistant, medical assistant or an office/practice manager–that helps patients navigate the complex process of obtaining access to prescribed biologic medications.

Biologic coordinators are important patient advocates in healthcare—yet too often, their work goes unrecognized.

Show your support today for Biologic Coordinators by using the hashtags #NationalBiologicCoordinatorsDay and/or #BeCauseYouCare!

Learn more about the importance of Biologic Coordinators
by downloading this educational fact sheet:

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