Will the US Move Away from Interchangeable Designations for Biosimilars?
On September 15, 2023, the Food and Drug Administration released draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency is accepting comments through November 17, 2023, and the finalized guidance will revise and replace the 2018 guidance for the industry entitled “Labeling for Biosimilar Products.”