FDA Proposes Distinct Naming Suffixes For Biosimilars, Biologics

FDA proposes to add suffixes to the nonproprietary names of both biosimilars and the brand biologics they reference, according to a long-awaited draft guidance on biosimilar naming that the agency released Thursday (Aug. 27). In addition to the draft guidance, the agency proposed a rule to rename six biologic products -- including the first U.S. approved biosimilar -- in accordance with the draft guidance. In the guide, FDA also seeks feedback on naming interchangeable biosimilars and their reference products, and...