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FDA Issues Guidance on Manufacturing Changes to Biosimilars and Interchangeable Biosimilars

Today, FDA issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products.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 FDA to support postapproval manufacturing changes to licensed (approved) biosimilar and interchangeable biosimilar products.

FDA previously provided recommendations for postapproval manufacturing changes to biosimilars as part of a September 2021 final guidance. The agency did not include recommendations for postapproval manufacturing changes to interchangeable biosimilars at that time. The agency has since determined the principles that apply to postapproval manufacturing changes to licensed biosimilar products are also relevant to licensed interchangeable biosimilar products and today’s guidance provides recommendations for both.

FDA is publishing this draft guidance to fulfill a commitment made in the 2022 reauthorization of the Biosimilar User Fee Act. Comments regarding the draft guidance should be submitted following the information in the notice of availability that will be posted in the Federal Register shortly.

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