The Priority Review

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interchangeable biosimilar

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  1. Regulation

    FDA finalizes guidance on post-approval manufacturing changes to biosimilars

    FDA announced the availability of a final guidance titled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." The guidance supersedes the draft issued July 23 2024 and withdraws Q&A I.20 from the Q&A biosimilar development guidance.