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.

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.

October 2022 Newsletter

November 17, 2022

ASBM Presents at WHO 75th INN Consultation

 

On October 18th, ASBM participated in the World Health Organization’s 75th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the nineteenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.

 

From the WHO’s Executive Summary of the 74th INN Consultation, at which ASBM presented in April 2022:

 

ASBM noted that it was a decade ago that the WHO recognised the need to improve biological PV and that a WHO survey in 2020 found that the lack of an international standard remains an issue of concern that can lead to PV problems. Several early supporters of universal distinct naming have gone their own way due to lack of WHO action, but have expressed willingness to harmonize should the WHO act. ASBM will continue to work with regulators worldwide to move a global nomenclature policy forward…The Chair added that the Expert Group is looking at how to progress naming for these biologics and that the concept that was developed previously, viz., the biological qualifier (BQ), will be taken forward and discussed at WHO management level. Thus, the continued presence of ASBM at these sessions has not been in vain.

 

Read the WHO’s summary of the 74th INN Consultation here.

 

 
Amgen Releases Full 2022 Biosimilar Trends Report

 

In October, Amgen released its full 2022 Biosimilar Trends Report. The report’s findings had been previewed earlier this year by Amgen’s Global Biosimilars Commercial Lead, Chad Pettit at a June 29th webinar hosted by ASBM and GaBI Journal.

 

View the webinar “Key Factors for Successful Uptake of Biosimilar Markets” here. Read GaBI Journal’s Meeting Report here. 

 

The full report further documents the tremendous success of the U.S. biosmilars program in promoting competition, increasing biosimilar uptake, and generating savings for the U.S. health system. From the report:

 

To date in the US, 39 biosimilars have received regulatory approval, and 22 products have been launched. These launches have helped create an estimated $21 billion in savings for the healthcare system over the past 6 years.

  • Biosimilars have gained significant U.S. market share in the majority of therapeutic areas where they have been introduced: 80% for filgrastim trastuzumab and bevacizumab biosimilars; 60% for rituximab biosimilars; and 40% for infliximab, pegfilgrastim, and erythropoietin-stimulating agent (ESA) biosimilars.
  • Biosimilars are attaining significant market share more quickly: for therapeutic areas with biosimilars launched in the last 3 years, the average share was 74%…prior to 2019, the average share after 3 years was 38%.

Medicare Part B reimburses providers for biosimilars at the biosimilar’s Average Sales Price (ASP) plus a 6% addon of the reference biologic’s ASP. In other words, Congress kept the field level by providing physicians the same add-on amount regardless of whether they prescribe a reference product or a biosimilar. This helps all manufacturers compete on equal terms.

 

The report also emphasized that continued stakeholder education was critical to the market’s continued success:

 

As biosimilars expand into new therapeutic areas and enter the pharmacy benefit, education will continue to be critical to instill patient, provider, and pharmacist confidence in the role of biosimilars as viable and integral treatment options.

 

Read the Amgen 2022 Biosimilar Trends Report here. 
View ASBM’s Key Success Factors Webinar here and access speaker presentations here. 
Read GaBI Journal’s Meeting Report about the webinar here.

 

 

 
ASBM Physician Survey Featured in Oncology Journal

 

ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here.  The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:

 

Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.

Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.

When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.

Read the Oncology Practice Management article here.

View Dr. McKibbin’s poster presentation here. 

View or download the poster here. 

 

 
ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics

 

On October 19th, ASBM Advisory Board Chair Philip Schneider participated in the 7th Annual National Policy & Advocacy Summit on Biologics, The event was hosted in Washington, DC by the Biologics Prescribers Collaborative and was also streamed online.

 

Professor Schneider appeared on the opening panel discussion entitled

“The Emerging Biologics Landscape”, which also featured Chad Pettit, Executive Director of Marketing at Amgen, and Wesley Mizutani, MD, a rheumatologist with Optum Medical Group. The discussion was moderated by David Charles, MD, founder of the Alliance for Patient Access.

Schneider discussed the pharmacist role regarding biosimilars, which includes keeping effectiveness & safety at the forefront of treatment decisions as our health system work to make responsible use of limited resources.

 

Another major topic of discussion was the role of pharmacy benefit managers (PBMs) in treatment decision-making and their impact on patient access to care. PBMs have eveloved from entities which simply processed claims, Schneider explained, into powerful entities with the ability to move market share through formulary design and rebates. This disrupts the autonomy of prescribers when a third party is effectively making clinical decisions. Pharmacists also feel they are losing control, as economics is often emphasized over medication effectiveness and patient health. Putting money into an intermediary often drives cost upward, Schneider observed.

View the panel discussion, “The Emerging Biologics Landscape”, followed by the rest of the event here. 

 

 

 
ASBM, IFA Observe World Sight Day 2022

 

World Sight Day is observed worldwide every year on the second Thursday of October. This World Health Organization-designated day fell on October 13th this year. The purpose of World Sight Day is to increase public awareness about blindness, vision impairment, vision care, and ocular issues. The WHO estimates that 1 billion people worldwide suffer from near or distant vision impairment due to delayed diagnosis and treatment. Although it can affect individuals of any age group, those over 50 years of age are more likely to experience it. Blindness or vision impairment can limit a person’s everyday life, prospects for employment and other aspects of their personal lives, including their ability to travel.

 

ASBM is quoted in a press release about World Sight Day from our partner the International Federation on Ageing (IFA) which is leading an educational campaign regarding the arrival of ophthalmic biosimilars in Canada:

 

In advance of World Sight Day on October 13th, the International Federation on Ageing (IFA) in partnership with national and global organizations wants to drive action for eye care, to improve the situation for those impacted by vision loss and blindness, now, and in the future. While global agencies support initiatives to improve, restore, and maintain vision for people around the world, many Canadians need to prepare for policy changes about their eye treatment that have the potential to impact patient and physician autonomy.

 

From the press release and informational packet:

 

“The Alliance for Safe Biologic Medicines (ASBM) supports the introduction of biosimilars as an important tool for offering patients new therapeutic options and reducing healthcare costs. The tremendous success of biosimilars in European markets has shown that countries need not sacrifice physician and patient’s choice to enjoy substantial savings. This is accomplished through competition between many reimbursed products, rather than forced switches. Physicians and patients in Canada deserve no less – yet they are increasingly seeing their choice restricted rather than expanded. With the arrival of ophthalmic biosimilars, we must heed the concerns of these physicians and their patients regarding unnecessary switching, so that we do not risk long-term harm to patients for short-term savings” states Michael Reilly, Executive Director, ASBM.

 

Read the IFA’s educational document- including a backgrounder on ophthalmic biosimilars, here.

 

 
FDA: “Incorrect” to Assume Interchangeables Are More Effective Than Biosimilars
As reported in Generics Bulletin October 10th, Dr. Sarah McMullen, India country director for the US Food and Drug Administration underscored that there’s no real distinction in the standards to determine the safety or efficacy for both biosimilars and interchangeable biosimilars, and put forth a “fact check” to dispel the general notion among patients that interchangeables are perhaps better than other approved biosimilars.

 

Dr. McMullen’s remarks were made while addressing the BioPharma Conclave 2022, and echo those made by Leah Christl, Executive Director of Biosimilars Global Regulatory and R&D Policy at Amgen, in a July 20 webinar hosted by ASBM and GaBI Journal. Dr. Christl, former Director of Therapeutic Biosimilars and Biologics at the FDA’s Office of New Drugs, said in her presentation:

 

This designation of a biosimilar as interchangeable does not imply anything about the quality of the product. Non-interchangeable biosimilars are held to the same standards as interchangeable biosimilars…an interchangeable is not a quote-unquote “better” biosimilar, it’s just a biosimilar that’s undergone additional testing to generate additional data and information to support meeting the statutory definition and ultimately be eligible for pharmacy-level substitution.

 

The webinar, entitled “Non-medical switching of biologicals/biosimilars: Canada, Europe and the US” is the subject of a Meeting Report to be published in the next issue of GaBI Journal.

 

View a recording of the ASBM/GaBI Webinar featuring Dr. Christl’s presentation, here.

 

Read the full article about the FDA comments at Generics Bulletin here (registration required).

 

 

 
 
ASBM/Ohio State University Biosimilars CE Course Adds New Module on Patient Perspectives

 

In October, ASBM recorded the latest entry in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. This course module, entitled “Patient Perspectives on Biosimilars”, represents part 6 of the 7-part series covering a wide range of biosimilar policy issues.

 

In this module, participants will hear different perspectives from the patient community regarding biosimilars and how they are made available to patients. ASBM Steering Committee Member Andrew Spiegel will share his perspective as the head of two international patient organizations (the Global Colon Cancer Association and World Patients Alliance) as well as sharing the perspectives of several other patient advocacy experts from the U.S., Europe, Canada, and Australia.

 

Upon completion, participants will be able to:

  1. Identify key benefits and challenges that biosimilars create for patients
  2. Describe concerns that patients have under different biosimilar access scenarios.
  3. Compare and contrast the roles of the physician and patient in treatment decisions in the different biosimilar markets examined.
  4. Discuss tactics the patient community have used to improve access to biosimilars and control over treatment.=

The final entry in the CE series, entitled “PBM and Payer Practices” and featuring Immediate Past ASBM Chair Madelaine Feldman, MD FACR; will be available in the coming weeks.

 

View all the available OSU College of Pharmacy CE courses here. (registration required).

View the course outline here.

View a promotional trailer for the CE series here.

 
ASBM’s Feldman Discusses Biosimilars in 2023 at STAT Forum

 

On October 12, ASBM Immediate Past Chair Madelaine Feldman, MD, FACR participated in a forum held by STAT, entitled “Biosimilars’ Meteoric Moment”. The forum focused on the long-awaited arrival of multiple adalimumab biosimilars in 2023 and asked experts from a variety of fields to speculate on what 2023 holds for the biosimilars market. Speakers included:

  • Madelaine A. Feldman, M.D., FACR, president, Coalition of State Rheumatology Organizations; clinical assistant professor of medicine, Tulane University School of Medicine
  • Steven Horvitz, president and founder, EMC Analytics Group
  • Darius Lakdawalla, Ph.D., director of research, USC Schaeffer Center for Health Policy & Economics; quintiles chair in pharmaceutical development and regulatory innovation, USC School of Pharmacy; professor, USC Price School of Public Policy
  • Michael Sherman, M.D., MBA, MS, executive vice president and chief medical officer, Point32Health
  • Ed Silverman, Pharmalot columnist, senior writer, STAT (moderator)
  • Thomas Newcomer, head of US market access, Samsung Bioepis (sponsor speaker)

During the one-hour panel discussion, Dr. Feldman discusses several factors which she believes will influence the success of the U.S. adalimumab biosimilar market, including interchangeability, recent federal legislation, and PBM formulary construction.

 

View video of the STAT Forum “Biosimilars’ Meteoric Moment” here.

 

 
ASBM Presents at World Drug Safety Congress

 

On October 4-5, 2022 ASBM Advisory Board Chair Philip Schneider participated in the World Drug Safety Congress Americas 2022, held in Boston, MA. The annual pharmacovigilance (PV) conference bills itself as “the largest commercial gathering of PV professionals in the world.

 

During the two-day conference, Prof. Schneider chaired both the Global PV Track and Advanced Therapies Track. 

 

In addition to chairing the Global PV track Professor Schneider also presented on the role of distinguishable biologic nomenclature in improving global pharmacovigilance. Distinct biologic nomenclature, he argued, promotes the more accurate tracking of biologic medicines, including biosimilars. In addition, a harmonized system such as that proposed by the WHO, would facilitate the sharing of that information internationally.

 

Learn more about the World Drug Safety Congress here.

 

 
American Academy of Ophthalmology Cautions Against Biosimilar Substitution

 

In October, the American Academy of Ophthalmology hosted its annual meeting in Chicago and attracted participants from around the world, including ophthalmologists, optometrists, opticians, and other eye health care professionals. The conference featured presentations focusing on the latest advances in comprehensive eye care, including medical, surgical, and optical care. One area of discussion at the meeting was the long-anticipated arrival of ophthalmic biosimilars. (The FDA approved the first ophthalmic biosimilar in September 2021.)

 

The AAO had released a statement earlier this year which raised concerns about differences in the inactive ingredients (excipients) between bevacizumab biosimilars and their reference products. Bevacizumab is often prescribed off-label for ophthalmic use. While a biosimilar product has no clinically meaningful differences in terms of safety, purity, and potency to the reference product for its labeled indications, The excipients –­ including the stabilizer or buffer — may differ from what is used in the reference product. While three bevacizumab biosimilars have been developed for use in the oncologic space, they have not been studied for ophthalmic indications and their inactive ingredients have not all been approved for use in the eye.

 

Among the statement’s recommendations:

  • For off-label use of biosimilars in the eye, the Academy strongly recommends against biosimilar substitution until there is robust clinical use data available for those indications.
  • Biosimilars may reduce health care costs if they are priced less than the reference product, but should be used only if there is clinical evidence and an FDA-approved indication supporting their use.
  • The Academy believes that a biosimilar alternative being added to coverage or preferred coverage status by an insurer for an ophthalmic condition must include robust clinical literature supporting its use for ophthalmic diseases because small variations in excipients can lead to significant and potentially blinding inflammatory complications when injected intravitreally.
  • The Academy does not support step-therapy; the choice of treatment should be that of a patient and their ophthalmologist.
  • The Academy strongly recommends against including these in step therapy regimens and/or as replacement for the reference product, bevacizumab, in the absence of sufficient clinical studies for eye disease.

Read the full AAO statement here.

 
UPCOMING EVENTS

 

ASBM-GaBI Webinar #3: Ophthalmic Biosimilars

Virtual – December 2022 (Date TBD)

 

Biosimilars Training Program Watch Party

Virtual (Register here) – December 7, 2022

 

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

 

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023

 

 

 

ASBM Chairman Named to ACG Board of Governors

November 10, 2022

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:
mckibbinheadshotcloseup4x5

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 Presents at Festival of Biologics 2022 Europe

November 8, 2022

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.

img_0471

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.

ASBM Presents at Festival of Biologics 2022 Europe

November 8, 2022

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.

img_0471

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.

logo logo logo