FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

BY LAURA DIANGELO, MPH, RACHEL COE, MSC

Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes. The new draft guidance gives considerations for applicants seeking new dosage form or strengths, and those manufacturing the product in a facility with other versions of the biological product. When finalized, this will supersede recommendations from a 2021 Q&A guidance.

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