FDA guidance on manufacturing changes to biosimilars

Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products.

This guidance provides biologic product manufacturers with recommendations on the nature and type of information they should provide to the FDA to support post-approval manufacturing changes to licensed (approved) biosimilar and interchangeable biosimilar products.

The FDA previously provided recommendations for post-approval manufacturing changes to biosimilars as part of a September 2021 final guidance. The agency did not include recommendations for post-approval manufacturing changes to interchangeable biosimilars at that time.