The world’s regulators agree: Biosimilars aren’t generics. Why is the FDA suddenly pretending they are?
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 […]
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. […]
