Latest News – Page 2 – Safe Biologics

ASBM Opposes CA Bill to Permit Pharmacy Substitution of Non-Interchangeable Biosimilars

March 26, 2026

ASBM recently submitted a letter opposing California Senate Bill 1094, which would permit generic-style pharmacy-level substitution of non-interchangeable biosimilars. While biosimilars are safe and effective, they are not generics—and substitution decisions for biologics should remain grounded in evidence, physician judgment, and patient-specific considerations. California’s current framework appropriately allows substitution only for biosimilars that meet the […]

FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety

March 17, 2026

Washington Examiner (Opinion): FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety March 15, 2026 | Dr. Cristina Beato The Trump Administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, many of these successes are overshadowed by slapdash decision-making at a key health agency, which significantly undermines the Administration’s goals, threatens treatment […]

Erratic FDA Leadership is Creating a Crisis of Confidence

February 22, 2026

by Michael Reilly, ASBM Executive Director It feels impossible these days to go a single week without news of another shocking policy move from the U.S. Food and Drug Administration that upends decades-old scientific consensus or agency norms regarding clinical safety data and drug approval standards. Consider the most recent example. Earlier this month, the […]

ASBM Statement Commending Senator Jim Banks for Introducing the SAFE Drugs Act of 2025

February 17, 2026

Download PDF version here February 16, 2026 The Alliance for Safe Biologic Medicines (ASBM) commends Senator Jim Banks (R-IN) for introducing the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE Drugs) Act of 2026 in the United States Senate. We also support the bipartisan companion bill (H.R. 6509), introduced in the House of Representatives by […]

ASBM Statement on FDA Commissioner’s Comments Regarding Compounded Medicines

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 […]

ASBM Submits Comments on FDA Draft Guidance Reducing the Role of Comparative Efficacy Studies in Biosimilar Approvals

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 […]

ASBM in GaBI Journal: “Biosimilars—Still Safe, Still Effective, Still Not Generics. Why Is FDA Pretending They Are?”

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 […]

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- […]

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 […]

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?