Trust is Built on Data: Preserving the FDA’s Evidence-Based Approach to Interchangeable Biosimilars

May 8, 2025

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) In a recent CBS News interview, newly appointed FDA Commissioner Dr. Marty Makary called for more robust clinical evidence before recommending the latest COVID-19 booster shots. “There’s a void of data,” Dr. Makary said, underscoring a renewed focus on restoring public trust through a […]

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Statement from the ASBM on Senate HELP Committee 340B Reform Report

April 29, 2025

April 29, 2025 The Alliance for Safe Biologic Medicines (ASBM) commends Senator Bill Cassidy and the Senate HELP Committee for their new report, “Congress Must Act to Bring Needed Reforms to the 340B Program.” The program is designed to support underserved populations by ensuring access to medicines by allowing qualifying entities to safety-net hospitals, community […]

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ASBM Statement on President Trump’s Executive Order Supporting Patients Who Depend on Small-Molecule Medicines

April 21, 2025

April 21, 2025  The Alliance for Safe Biologic Medicines (ASBM) commends President Donald J. Trump for his leadership in issuing an executive order to address the harmful “pill penalty” contained within the Inflation Reduction Act (IRA). This provision, enacted during the Biden administration, imposes price controls on small-molecule medicines—commonly delivered in pill or tablet form—just […]

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Debunking Misinformation on Interchangeable Biosimilars

March 20, 2025

A recent IQVIA report funded by the generics industry trade group Association for Accessible Medicines is propagating several misleading claims about interchangeable biosimilars. ASBM has frequently addressed misinformation efforts about interchangeablity biosimilars in recent months, to correct the record and reinforce the rigorous FDA standards now protecting patient safety and treatment stability. Here are some […]

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ASBM Praises Introduction of the EPIC Act

March 7, 2025

FOR IMMEDIATE RELEASE  March 7, 2025 Arlington, VA – The Alliance for Safe Biologic Medicines (ASBM) today expressed its support and gratitude to Senators Thom Tillis (R-NC), Ted Budd (R-NC), Marsha Blackburn (R-TN), James Lankford (R-OK), and Steve Daines (R-MT) for their leadership in introducing the Ensuring Pathways to Innovative Cures (EPIC) Act (S. 832) […]

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Fact Sheet: the IRA’s “Pill Penalty”

March 7, 2025

Click below to read ASBM member WeWorkForHealth’s Fact Sheet on the effects of the IRA’s “Pill Penalty”, also known as the “Small-Molecule Penalty”, which disincentivizes R&D on chemically-derived medicines used to treat many serious conditions like cancer and heart disease: Click below to view

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ASBM Urges Congress to Support EPIC Act: Remove IRA’s “Pill Penalty” to Ensure Continued R&D for Small-Molecule Drugs

March 5, 2025

On February 25th, the House of Representatives introduced the Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) an important step toward fixing the Inflation Reduction Act’s (IRA) small molecule pill penalty. Small-molecule drugs typically come in pill or tablet form, and comprise 90% of prescriptions filled in the U.S. The Senate introduced its companion […]

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ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

February 27, 2025

On February 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR joined Members of Congress and other high-profile supporters of PBM reform at a Congressional event urging leadership to include critical bipartisan PBM reform legislation in the anticipated March funding package. The event, titled “Finish the Job! Pass PBM Reform Now” included welcome remarks from […]

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ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA

February 25, 2025

On February 20th, Philip Schneider, ASBM Advisory Board Chair, taught a 2-hour class at the Ohio State University College of Pharmacy that examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry.  The module examined three current policy issues related to biosimilars: Pharmacy students were given basic information about […]

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ASBM Responds to PCMA: Put Patients First, Not PBM Profits

December 12, 2024

Press Release ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that […]

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