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On January 20, ASBM submitted formal comments to the U.S. Food and Drug Administration on the agency’s October 2025 draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy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