Comment from The Alliance for Safe Biologic Medicines

Summary: The Alliance for Safe Biologic Medicines (ASBM) opposes the proposed guidance because it allows for the use of comparative clinical data from non-U.S.-licensed products to support biosimilarity. They argue that this move toward "genericization" undermines established scientific standards, introduces unacceptable uncertainty, and risks diminishing physician and patient confidence in the safety and effectiveness of biosimilars.