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 Representatives Discuss Biosimilars on AI Arthritis Podcast
On August 31st, several ASBM representatives joined Tiffany Westrich-Robertson, CEO of the International Foundation for Autoimmune & Autoinflammatory Diseases, to record an episode of the AI Arthritis Voices 360 podcast. The episode discussed examined policy issues surrounding biosimilars and how these affect patients.
ASBM was represented in the discussion by Executive Director Michael Reilly; Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association (GCCA).
Discussion topics included the basics of biosimilars, how they differ from traditional biological drugs, and how and when they may be substituted. The practice of non-medical switching by third parties is controversial among physicians due to patient-specific differences and a patient’s unique medical history, explained Dr. McKibbin: “Treatment plans are not one size fits all”.
Andrew Spiegel offered his perspective as a patient advocate: “The patient community is excited about biosimilars- but we want these policies to work for patients.”
Mr. Reilly provided an overview of different biosimilar substitution policies worldwide, and emphasized that the most successful biosimilar markets have been those which allowed physician and patient control of treatment decisions: Europe has the most robust and successful biosimilar markets in the world; and in every European country, physicians and patients are free to choose among many products including the originator and several biosimilars-all are reimbursed. This competition has led to tremendous savings.
Keeping the Discussion Going into 2023 and Beyond
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| OSU College of Pharmacy Adds Two New Modules to ASBM CE Course
In August, ASBM recorded two new entries in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. These represent part 4 and 6 of the 7-part series covering a wide range of biosimilar policy issues. View the previous three entries here.
Module 4: Physician Perspectives on Biosimilars In this module, ASBM Chair Ralph McKibbin, MD FACP FACG AGAF shares survey data from physicians in 13 countries, including U.S. (n=401, 2021) and Europe (n=579, 2019). Physician attitudes on a variety of aspects of biosimilars are examined including: confidence in their safety and efficacy, comfort level with prescribing biosimilars, physician-led switching of patients, third-party switching for cost/coverage reasons, implications of interchangeability designations and distinct suffixes, and payer coverage and reimbursement practices. The lecture is followed by a discussion portion between Dr. McKibbin and OSU College of Pharmacy Professor Philip Schneider.
Module 5: The Biosimilar Market This module is hosted by Professor Philip Schneider and examines the reasons for increasing biosimilar uptake, and various factors which contribute to their gaining market share. Among these are building physician confidence through data, robust post-market surveillance to address concerns about abbreviated pathways, the preservation of physician and patient choice, multiple payer-reimbursed products competing on a level playing field, and downward price pressure resulting from competition. The mature biosimilar markets of Europe are analyzed in great detail, and lessons regarding best practices are drawn. The current U.S. biosimilar market is also discussed, including an examination of biosimilars which have achieved significant, even dominant, market shares.
Future entries in the CE series will include Patient Perspectives on Biosimilars, featuring ASBM Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association; and PBM and Payer Practices, featuring Immediate Past ASBM Chair Madelaine Feldman, MD FACR.
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.
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| Andrew Spiegel: Price Controls on Drugs Mean Patients Will Suffer
On August 2nd, an op-ed by Andrew Spiegel was published in which he argues against price controls for advanced therapies- including biologic medicines used to treat cancer. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a Member of ASBM’s Steering Committee.
In the op-ed, Spiegel lays out how the H.R. 5378/The Inflation Reduction Act’s provision permitting the federal government to “negotiate” lower drug prices with manufacturers will result in fewer innovative drugs for patients:
In other words, companies and investors are assuming a great deal of risk when they invest in a new drug — a risk multiplied by the Inflation Reduction Act’s price controls.
A recent study by the University of Chicago, for example, found that the legislation’s price controls would result in a more than 18% drop in investment in drug research through 2039, with an estimated 135 fewer drugs being introduced over that time period.
I certainly support making prescriptions more affordable, but the drug-price “negotiation” provision of the Inflation Reduction Act is a misguided way to do that. Let’s hope lawmakers realize they are making a serious misdiagnosis — before it is too late.
The Inflation Reduction Act was signed into law August 16th, 2022.
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| FDA Approves Third Interchangeable Biosimilar, First Interchangeable Ophthalmic
On August 2nd, the Food and Drug Administration (FDA) approved the Cimerli (ranibizumab-eqrn) injection as interchangeable with, Lucentis (ranibizumab injection).This is the 37th biosimilar approval in the United States, the third interchangeable biosimilar approved, and the first interchangeable in the ophthalmic space.
Cimerli is a vascular endothelial growth factor (VEGF) inhibitor and is approved for the same indications approved for its reference product, Lucentis.
A biosimilar is a biological product that is highly similar to an existing FDA-approved biological product, known as a reference product. The biosimilar must also have no clinically meaningful differences in terms of safety and effectiveness from the reference product. A biosimilar sponsor may choose to also seek an interchangeability determination by demonstrating that their product also meets specific requirements outlined in the Public Health Service Act.
In addition to meeting the same standard for biosimilarity, additional requirements for interchangeability include a determination that the proposed interchangeable can be expected to produce the same clinical result as the reference product in any given patient; and that the risk in terms of safety or diminished efficacy of alternating or switching between the proposed interchangeable and the reference product is not greater than the risk of using the reference product without such alternation or switch.
An interchangeable product may be substituted for the reference product at the pharmacy without consulting the prescriber—a practice commonly called “pharmacy-level substitution” — subject to state law.
Read more about the approval here.
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| Coming Soon: ASBM & GaBI Webinar Reports
ASBM and the Generics and Biosimilars Initiative are preparing reports on the two webinars the organizations recently co-hosted. The reports will appear in an upcoming issue of GaBI Journal. The reports will summarize the presentations of the speakers and address audience questions unable to be answered answer during the programs due to time constraints. The two webinars may be viewed at the links below. On July 20th, 2022 ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a 2-hour webinar 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. The Non-Medical Switching webinar was the second in a series of webinars hosted by ASBM and GaBI this year highlighting key biosimilar policy issues. The first entry, hosted June 29th, examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US” and may be watched here. The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in October 2022. More information will be available soon.
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