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Guidance Documents/Guidance-Document/Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

July 23, 2024

July 23, 2024

Center for Drug Evaluation and Research

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