February 6, 2026
February 6, 2026 The Alliance for Safe Biologic Medicines (ASBM) welcomes FDA Commissioner Marty Makary’s comments on the social media platform X affirming that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs” and warning that the agency will “take swift action against companies mass-marketing illegal copycat drugs.” These remarks accurately reflect […]
January 20, 2026
On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. In the comments, ASBM supports FDA’s recognition that comparative analytical assessments (CAA) have become increasingly […]
January 20, 2026
On January 12, the Brussels-based GaBI Journal published an editorial by ASBM Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Steering Committee member Andrew Spiegel examining an abrupt and troubling shift in U.S. biosimilars policy. In the article, the authors argue that while biosimilars have consistently demonstrated safety and effectiveness, they are not […]
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- […]
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 […]
November 5, 2025
The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?
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 […]
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 […]
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. […]
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 […]
