Experts Examine 340B Program, Reform Efforts in ASBM/GCCA Webinar

January 6, 2026

On December 12th, ASBM and the Global Colon Cancer Association (GCCA) hosted a one-hour webinar discussing the 340B Drug Discount Program, a federal program designed to help hospitals and clinics serving patients in need. The webinar, entitled “Reforming 340B: Ensuring the Discount Program Delivers for Patients” discussed how the program has strayed from its original mission- […]

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Register for the December 12th ASBM/GCCA 340B Webinar!

December 11, 2025

  Reforming 340B: Ensuring the Discount Program Delivers for Patients December 12, 2025 • 11:00 AM – 12:00 PM ET Hosted by the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) Register Now The 340B Drug Discount Program was created to help hospitals and clinics stretch limited resources to serve […]

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Fact Sheet: Stop the “Genericization” of Biosimilars

November 5, 2025

The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?

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ASBM Submits Comments Urging FDA to Maintain Stringent Approval Standards, Opposing “Genericization” of Biosimilars

October 21, 2025

On October 19th, ASBM submitted detailed comments to the U.S. Food and Drug Administration regarding its September 19 public workshop, Advancing the Development of Interchangeable Products: Identifying Future Needs (Docket No. FDA-2025-N-2787). ASBM expressed strong concern over signals that FDA may move toward “genericizing” biosimilars—modeling their approval and substitution on small-molecule generics—calling such a shift “scientifically inappropriate […]

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A Step Backward for Medication Safety and Confidence: FDA’s New Biosimilar Plan Revives Biden-Era “Genericization” Policy

October 1, 2025

October 31, 2025 ASBM: Biosimilars are not generics—so why is FDA pretending they are?  Learn more: ASBM Fact Sheet- Stop the “Genericization” of Biosimilars  WASHINGTON, D.C. — The Alliance for Safe Biologic Medicines (ASBM) today expressed strong opposition to the Department of Health and Human Services’ continuation of a Biden-era regulatory initiative that inaccurately portrays biosimilars as “generic […]

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ASBM Announces Retirement of Doug Badger,Welcomes Beato and Downing to Board

July 7, 2025

ARLINGTON, VA — July 7, 2025 — The Alliance for Safe Biologic Medicines (ASBM) today announced the retirement of longtime Board member Doug Badger, and the appointment of two new members to its Board of Directors: Cristina V. Beato, MD, and Chris Downing, both of whom previously served in senior leadership roles at the U.S. […]

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MFN: Medicines For No-One

June 3, 2025

What is MFN?—Why It’s a Threat to Patients The Most Favored Nation (MFN) drug pricing policy ties U.S. medicine prices to those in countries with strict government price controls. This may sound like a win for patients, but MFN imports the very systems that limit access, delay innovation, and lead to higher death rates abroad—especially […]

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ASBM Statement on Executive Order Implementing MFN Pricing

May 15, 2025

Statement from the Alliance for Safe Biologic Medicines (ASBM) on the Administration’s Executive Order Implementing MFN Pricing May 15, 2025 The Alliance for Safe Biologic Medicines (ASBM) opposes the Administration’s May 12, 2025 Executive Order establishing Most Favored Nation (MFN) pricing for prescription drugs.  This approach would import foreign price controls from countries where patients […]

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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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