Rocky Mountain Life Science Investor & Partnering Conference

September 21-23, 2011
Denver, Colorado
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ASBM Statement on FDA Commissioner’s Comments Regarding Compounded Medicines

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ASBM Submits Comments on FDA Draft Guidance Reducing the Role of Comparative Efficacy Studies in Biosimilar Approvals

On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy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?”

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 […]