Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| 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:
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.
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| 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.
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| 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).
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| 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.
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| 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.
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| 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.
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