FDA To Drug Makers: Don’t Imply Reference Drugs, Interchangeables Superior To Biosimilars

FDA warns drug makers in a new draft guidance not to imply in their promotional and advertising materials that reference drugs are superior to their biosimilars, or that interchangeable biosimilars are clinically distinct from other biosimilars. The warning that such statements could be “false or misleading” comes as the Biden administration takes regulatory steps to increase use of biosimilars, and asks Congress to remove the distinction between biosimilars with interchangeability status and those without. The language is included in a...