FDA (CDER)
GUIDANCE FINAL
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers
Published: 10/9/2026Detected: 10/9/2026
Summary preview
Clarifies how FDA expects sponsors of biosimilar and interchangeable biosimilar products to manage and document postapproval manufacturing changes, including how comparability and regulatory reporting should be…
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