ASBM’s Feldman and Reilly Present at Treatment Choice Summit

February 2, 2023

On January 31st, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR and Executive Director Michael Reilly participated in the 2023 Treatment Choice Summit, held in Washington, DC.

tcs-feldman
Dr. Feldman moderated the first panel discussion, Patient and Provider Perspectives on the Impact of Treatment Choice. The purpose of the discussion was to identify barriers to treatment choice and how these impact patients, their out-of-pocket costs, and the patient-physician relationship.
tcs-reilly-closeupMr. Reilly appeared on a second panel, entitled Recent Policy Initiatives to Protect Treatment Choice, which examined ways in which effective advocacy can protect treatment choice. Mr. Reilly emphasized the importance to physicians of maintaining control over treatment choice, citing ASBM’s extensive research into physician perspectives on non-medical switching:
“ASBM has surveyed physicians around the world and we have consistently seen that while they are confident in biosimilars they strongly believe that treatment decisions should be made by physicians in consultation with the patient – not by a third party for cost reasons.”
A 2021 ASBM survey of 401 U.S. physicians found that the majority (58%) are uncomfortable with a switch initiated by a third-party for non-medical reasons. 89% maintain that they, with their patients, should have sole control over treatment choices; and 67% consider it “very important” or “critical” that they are able to prevent a substitution they feel is inappropriate.
Read a whitepaper on the U.S. physician survey here. 

Ontario Announces Forced-Substitution Policy

January 30, 2023

In December, the Ontario government announced that it would follow other Canadian provinces including British Columbia, Alberta, Quebec and require mandatory switching to biosimilars.  a mandatory switching in 2020, but implementation was delayed due to the COVID-19 pandemic. A nine-month transition period will begin March 31st. From the government’s announcement:

Ontarians receiving coverage under the ODB program for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan®, will be required to transition to the biosimilar version by December 29, 2023. During the transition period between March 31 and December 29, 2023, patients are encouraged to discuss a transition plan with their health care provider through in-person, telephone or virtual visits. Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.

 

While the Ontario announcement justifies the policy by citing 15 years of successful use of biosimilars in Europe, it is important to note that in nearly every European country physicians retain free choice between multiple reimbursed products and forced substitution is rare. A 2017 survey of 403 Canadian physicians revealed that Canadian physicians are generally opposed to forced substitution: 

  • 64% were not comfortable with a third party switching a patient’s medicine for non-medical reasons, as would occur under the Ontario policy. 28% were somewhat comfortable, and only 6% were completely comfortable.
  • 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.
  • 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”.

Read the announcement from the Ontario government here. 

ASBM Members: Get Free Access to ASBM/OSU Biosimilars Course

January 10, 2023

The Ohio State College of Pharmacy has provided ASBM with access codes for our Members who wish to view the first four modules of the ASBM/OSU College of Pharmacy Biosimilars Course at no charge:

Biosimilars Module 1: Introduction to Biologics and Biosimilars 
(Prof. Philip Schneider, MS FASHP FFIP)

Biosimilars Module 2: Substitution and Interchangeability
(Prof. Philip Schneider, MS FASHP FFIP)

Biosimilars Module 3: Biologic and Biosimilar Pharmacovigilance  
(Prof. Philip Schneider, MS FASHP FFIP)

Biosimilars Module 4: Physicians’ Perspectives on Biosimilars 
(Ralph McKibbin, MD, FACP, FACG, AGAF)

To request free access to the promotional codes for ASBM members, please contact Ray Patnaude at media@safebiologics.org
Promotional codes will be made for the remaining modules in the coming weeks.
View all available modules in the ASBM/OSU Biosimilars Course here.

ASBM Adds Module on PBM Practices to Ohio State University Biosimilars Course

January 10, 2023

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.

In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administered/pharmacy side) is examined in detail and the differences in these two sub-markets are highlighted: in particular, the degree to which savings can be achieved, and the role played by middlemen and manufacturer rebates in driving up rather than lowering costs. Utilization management tools used by payers (including non-medical switching and step therapy) are described, as are proposed regulations and legislation to restrict such practices.

Upon completion, students will be able to:
  1. Discuss the role of pharmaceutical benefit managers (PBMs) in the U.S. drug distribution system
  2. Explain the effects of competition on drug pricing under provider-administered and patient-administered drugs.
  3. Identify several utilization management techniques used by PBMs to influence which medicine the patient receives.
  4. Describe concerns that patients and physicians have regarding these PBM practices.
  5. Discuss potential legislative approaches under consideration to address concerns with these PBM practices.

View all available modules of the ASBM/OSU Biosimilars Course here. 

 

December 2022 Newsletter

January 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course

 

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.

 

In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administered/pharmacy side) is examined in detail and the differences in these two sub-markets are highlighted: in particular, the degree to which savings can be achieved, and the role played by middlemen and manufacturer rebates in driving up rather than lowering costs. Utilization management tools used by payers (including non-medical switching and step therapy) are described, as are proposed regulations and legislation to restrict such practices.

 

Upon completion, students will be able to:
  1. Discuss the role of pharmaceutical benefit managers (PBMs) in the U.S. drug distribution system
  2. Explain the effects of competition on drug pricing under provider-administered and patient-administered drugs.
  3. Identify several utilization management techniques used by PBMs to influence which medicine the patient receives.
  4. Describe concerns that patients and physicians have regarding these PBM practices.
  5. Discuss potential legislative approaches under consideration to address concerns with these PBM practices.

View all available modules of the ASBM/OSU Biosimilars Course here. 

 

 
Free Access to ASBM/OSU Biosimilars Course for ASBM Members

 

The Ohio State College of Pharmacy has provided ASBM with access codes for our Members who wish to view the first four modules of the ASBM/OSU College of Pharmacy Biosimilars Course at no charge:

Biosimilars Module 1: Introduction to Biologics and Biosimilars 
(Prof. Philip Schneider, MS FASHP FFIP)
Biosimilars Module 2: Substitution and Interchangeability
(Prof. Philip Schneider, MS FASHP FFIP)
Biosimilars Module 3: Biologic and Biosimilar Pharmacovigilance  
(Prof. Philip Schneider, MS FASHP FFIP)
Biosimilars Module 4: Physicians’ Perspectives on Biosimilars 
(Ralph McKibbin, MD, FACP, FACG, AGAF)

To request free access to the course, email Ray Patnaude at media@safebiologics.org.
Promotional codes will be made for the remaining modules in the coming weeks.
View all available modules in the ASBM/OSU Biosimilars Course here.
GaBI Journal Publishes Paper on ASBM US Physician Survey

 

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

 

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar product. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

 

 

 

 
Ontario Announces Forced-Substitution Policy

 

In December, the Ontario government announced that it would follow other Canadian provinces including British Columbia, Alberta, Quebec and require mandatory switching to biosimilars.  a mandatory switching in 2020, but implementation was delayed due to the COVID-19 pandemic. A nine-month transition period will begin March 31st. From the government’s announcement:
Ontarians receiving coverage under the ODB program for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan®, will be required to transition to the biosimilar version by December 29, 2023. During the transition period between March 31 and December 29, 2023, patients are encouraged to discuss a transition plan with their health care provider through in-person, telephone or virtual visits. Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.

 

While the Ontario announcement justifies the policy by citing 15 years of successful use of biosimilars in Europe, it is important to note that in nearly every European country physicians retain free choice between multiple reimbursed products and forced substitution is rare. A 2017 survey of 403 Canadian physicians revealed that Canadian physicians are generally opposed to forced substitution: 

  • 64% were not comfortable with a third party switching a patient’s medicine for non-medical reasons, as would occur under the Ontario policy. 28% were somewhat comfortable, and only 6% were completely comfortable.
  • 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.
  • 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”.

Read the announcement from the Ontario government here. 

 

 
FDA Approves Eighth Adalimumab Biosimilar

 

On December 13th, the US Food and Drug Administration (FDA) approved its eighth biosimilar for Humira (adalimumab): Idacio (adalimumab-aacf).

 

Idacio is a tumor necrosis factor (TNF) blocker that blocks the production of TNF-alpha to reduce inflammation in the joints and skin. Idacio is indicated to treat a range of autoimmune disorders such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. It is expected to launch in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).

 

The approval brings the total number of biosimilars approved in the U.S. to forty.

 

Read more about the approval here.

 

 
UPCOMING EVENTS

 

The 2023 Treatment Choice Summit

Washington, DC – January 31, 2023

 

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

 

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023

 

 

GaBI Journal Publishes Paper on ASBM US Physician Survey

December 20, 2022

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar product. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

 

November 2022 Newsletter

December 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe

 

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

  • 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
  • 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
  • Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

 

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

 

Read the GaBI Journal report of the webinar here.

 

View Professor Schneider’s Festival of Biologics presentation here.

 

View ASBM’s Festival of Biologics poster here. 

 

 
Senate Bill Would Ban Switching Studies for Interchangeable Biosimilars

 

On November 17th, Utah Sen. Mike Lee introduced S.6, the Biosimilar Red Tape Elimination Act, a bill which would prohibit the FDA requiring switching studies for biosimilars to gain interchangeability status. Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)
The new bill is aiming to increase competition within the biological drug market and reduce consumer costs by eliminating what its authors perceive as barriers to access for biosimilars. From the bill’s language:
“(B) CERTAIN STUDIES NOT REQUIRED.— The Secretary may not require, for a determination of interchangeability described in sub paragraph (A), that a biological product undergo studies that assess the risks of alternating or switching between use of the biological product and the reference product.’’
ASBM’s recent survey of 401 U.S. physicians found that a biosimilar being designated as “interchangeable” by the FDA makes a majority (57%) more comfortable prescribing it, and with pharmacy-level substitution in place of the originator (59%).
In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched. The Lee bill would remove such data requirements.
While the term “interchangeable biosimilar” has a precise legal definition in the U.S., in September the European Medicines Agency declared all biosimilars “interchangeable” (meaning “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.”)
Notably, the EMA statement does not weigh in on biosimilar substitution policy, which is left to individual member states. In nearly every European country, the automatic substitution of biosimilars in not permitted, and the choice of which product to prescribe rests with the physician.
Read about the Biosimilar Red Tape Elimination Act here. 
ASBM Chairman Named to ACG Board of Governors

 

In November, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF was named to the American College of Gastroenterology’s (ACG’s) Board of Governors. From ACG’s announcement:

 

Dr. Ralph D McKibbin has been selected to serve as a Governor of the American College of Gastroenterology. He will represent the members of Western Pennsylvania. The Board of Governors acts as a two-way conduit between College leadership and the membership at large. The ACG Governors also act as representatives on important issues facing gastroenterologists and organized medicine at large at both the national and state levels with advocacy activities occurring with Federal and State bodies as well as professional associations on regional, state and national levels.

 

A practicing gastroenterologist in Altoona, PA, Dr. McKibbin has served as ASBM Chairman since September 2021. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC).

 

More information about the ACG Board of Governors may be found at the ACG website here. (registration required).

 

 

 
ASBM Members Share Patient Perspectives at GRx+Biosims Conference

 

On November 9th, two ASBM Steering Committee members participated in the 2022 Generics and Biosimilars Conference (GRx+Biosims), held in Bethesda, MD. Andrew Spiegel of the Global Colon Cancer Association and Gavin Clingham of the Alliance for Patient Access both shared patient perspectives on biosimilars at a panel entitled “The Patient Voice in Drug Development”.

 

The purpose of the discussion was to hear from both the FDA and patient advocacy groups involved in this space about how the patient voice and experience can be harnessed to speed the development of and access to generics and biosimilars, and the tools that can be used to improve the patient perspective in this process.

 

Other speakers included representatives from the FDA’s Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER): Sarah Ibrahim, PhD, PharmD, Associate Director for Global Regulatory Affairs at the Office of Generic Drugs at CDER; and Partha Roy, PhD, Director of the Office of Bioequivalence at CDER.

 

The conference was sponsored by the Biosimilars Council, a division of the Association for Accessible Medicines. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

 

Read more about the 2022 GRx+Biosims Conference here.

 

 
ASBM Submits Comments on Minnesota Health Plan Legislation

 

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

 

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

 

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

 

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

 

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

 

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

 

Read ASBM’s comment letter here.

 

 

 
FDA Approves Second Interchangeable Insulin

 

On November 17th, the U.S. FDA approved its second interchangeable insulin product, Rezvoglar(insulin glargine-aglr).
Manufactured by Eli LIlly, it is the second interchangeable biosimilar to Lantus (insulin glargine) and the fourth interchangeable biosimilar product overall. Interchangeable biosimilars may be substituted in all 50 states without the involvement of the prescribing physician.

 

Learn more about the approval here. 

 

 

November 2022 Newsletter

December 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe

 

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

  • 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
  • 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
  • Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

 

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

 

Read the GaBI Journal report of the webinar here.

 

View Professor Schneider’s Festival of Biologics presentation here.

 

View ASBM’s Festival of Biologics poster here. 

 

 
Senate Bill Would Ban Switching Studies for Interchangeable Biosimilars

 

On November 17th, Utah Sen. Mike Lee introduced S.6, the Biosimilar Red Tape Elimination Act, a bill which would prohibit the FDA requiring switching studies for biosimilars to gain interchangeability status. Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)
The new bill is aiming to increase competition within the biological drug market and reduce consumer costs by eliminating what its authors perceive as barriers to access for biosimilars. From the bill’s language:
“(B) CERTAIN STUDIES NOT REQUIRED.— The Secretary may not require, for a determination of interchangeability described in sub paragraph (A), that a biological product undergo studies that assess the risks of alternating or switching between use of the biological product and the reference product.’’
ASBM’s recent survey of 401 U.S. physicians found that a biosimilar being designated as “interchangeable” by the FDA makes a majority (57%) more comfortable prescribing it, and with pharmacy-level substitution in place of the originator (59%).
In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched. The Lee bill would remove such data requirements.
While the term “interchangeable biosimilar” has a precise legal definition in the U.S., in September the European Medicines Agency declared all biosimilars “interchangeable” (meaning “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.”)
Notably, the EMA statement does not weigh in on biosimilar substitution policy, which is left to individual member states. In nearly every European country, the automatic substitution of biosimilars in not permitted, and the choice of which product to prescribe rests with the physician.
Read about the Biosimilar Red Tape Elimination Act here. 
ASBM Chairman Named to ACG Board of Governors

 

In November, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF was named to the American College of Gastroenterology’s (ACG’s) Board of Governors. From ACG’s announcement:

 

Dr. Ralph D McKibbin has been selected to serve as a Governor of the American College of Gastroenterology. He will represent the members of Western Pennsylvania. The Board of Governors acts as a two-way conduit between College leadership and the membership at large. The ACG Governors also act as representatives on important issues facing gastroenterologists and organized medicine at large at both the national and state levels with advocacy activities occurring with Federal and State bodies as well as professional associations on regional, state and national levels.

 

A practicing gastroenterologist in Altoona, PA, Dr. McKibbin has served as ASBM Chairman since September 2021. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC).

 

More information about the ACG Board of Governors may be found at the ACG website here. (registration required).

 

 

 
ASBM Members Share Patient Perspectives at GRx+Biosims Conference

 

On November 9th, two ASBM Steering Committee members participated in the 2022 Generics and Biosimilars Conference (GRx+Biosims), held in Bethesda, MD. Andrew Spiegel of the Global Colon Cancer Association and Gavin Clingham of the Alliance for Patient Access both shared patient perspectives on biosimilars at a panel entitled “The Patient Voice in Drug Development”.

 

The purpose of the discussion was to hear from both the FDA and patient advocacy groups involved in this space about how the patient voice and experience can be harnessed to speed the development of and access to generics and biosimilars, and the tools that can be used to improve the patient perspective in this process.

 

Other speakers included representatives from the FDA’s Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER): Sarah Ibrahim, PhD, PharmD, Associate Director for Global Regulatory Affairs at the Office of Generic Drugs at CDER; and Partha Roy, PhD, Director of the Office of Bioequivalence at CDER.

 

The conference was sponsored by the Biosimilars Council, a division of the Association for Accessible Medicines. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

 

Read more about the 2022 GRx+Biosims Conference here.

 

 
ASBM Submits Comments on Minnesota Health Plan Legislation

 

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

 

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

 

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

 

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

 

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

 

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

 

Read ASBM’s comment letter here.

 

 

 
FDA Approves Second Interchangeable Insulin

 

On November 17th, the U.S. FDA approved its second interchangeable insulin product, Rezvoglar(insulin glargine-aglr).
Manufactured by Eli LIlly, it is the second interchangeable biosimilar to Lantus (insulin glargine) and the fourth interchangeable biosimilar product overall. Interchangeable biosimilars may be substituted in all 50 states without the involvement of the prescribing physician.

 

Learn more about the approval here. 

 

 

GaBI Publishes Report on ASBM Webinar on Biosimilar Success Factors

December 1, 2022

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The report summarizes the presentations from the June 29th webinar which examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US”. View the webinar below:

The report also addresses audience questions that were unable to be answered during the programs due to time constraints.

GaBI is also preparing a report on the second webinar, hosted July 20th, 2022 entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch video of the Non-Medical Switching webinar here. 

These webinars are the first two in a series. The next topic will be “Ophthalmic Biosimilars” in November 2022. More information will be available soon.

Read GaBI’s report on Webinar #1 here.

 

ASBM Members Share Patient Perspectives at GRx+Biosims Conference

November 20, 2022

On November 9th, two ASBM Steering Committee members participated in the 2022 Generics and Biosimilars Conference (GRx+Biosims), held in Bethesda, MD. Andrew Spiegel of the Global Colon Cancer Association and Gavin Clingham of the Alliance for Patient Access both shared patient perspectives on biosimilars at a panel entitled “The Patient Voice in Drug Development”.

The purpose of the discussion was to hear from both the FDA and patient advocacy groups involved in this space about how the patient voice and experience can be harnessed to speed the development of and access to generics and biosimilars, and the tools that can be used to improve the patient perspective in this process.

Other speakers included representatives from the FDA’s Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER): Sarah Ibrahim, PhD, PharmD, Associate Director for Global Regulatory Affairs at the Office of Generic Drugs at CDER; and Partha Roy, PhD, Director of the Office of Bioequivalence at CDER.

The conference was sponsored by the Biosimilars Council, a division of the Association for Accessible Medicines. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

Read more about the 2022 GRx+Biosims Conference here.

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