ASBM has released a new fact sheet explaining the risks posed by the Biosimilar Red Tape Elimination Act (BRTEA, S. 1954). Today, FDA evaluates each biosimilar individually before determining whether it is interchangeable—meaning it may be substituted at the pharmacy without the prescribing physician’s approval. BRTEA would eliminate that product-by-product scientific review and automatically deem […]
August 6, 2026 – ARLINGTON, VA The Alliance for Safe Biologic Medicines (ASBM) commends Senators Jerry Moran (R-KS), Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Tim Kaine (D-VA), John Boozman (R-AR), and John Hickenlooper (D-CO) for introducing the bipartisan Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act, […]
By Peter J. PittsJune 16, 2026 Read the full article at RealClearHealth One of the first things I learned during my time at the FDA was that biology rarely cooperates with political talking points. That’s not a criticism. It’s simply reality. Biological medicines are complicated. Patients are complicated. Scientific evidence is often complicated. Anyone looking for […]
