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FDA Finalizes Guidance on Postapproval Manufacturing Changes for Biosimilars and Interchangeable Biosimilars   

Today, FDA issued a final guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers. This finalizes the draft guidance of the same title published July 23, 2024. 

This guidance provides biological 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. The final version includes revisions made in response to public comments received on the draft guidance. Key revisions to the final guidance include: 

• Aligns recommendations provided in the guidance with the International Council for Harmonisation (ICH) guidance for industry Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (June 2005). 
• Clarifies recommendations for using data from the applicant’s original 351(k) BLA to support the manufacturing change. 
• Clarifies recommendations for the nature and type of information to support approval of a dosage form or strength that was not previously licensed under the 351(k) BLA. 

This final guidance fulfills a commitment made in the 2022 reauthorization of the Biosimilar User Fee Act. 

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