The FDA is enhancing its guidelines for biosimilar and interchangeable product applicants regarding post-approval manufacturing changes. The updated draft guidance focuses on new considerations for applicants looking to introduce new dosage forms or strengths, or to produce the product in facilities that also handle different versions of the biological product. This development is aimed at meeting a biosimilar user fee commitment. When this guidance is finalized, it will replace the recommendations established in the 2021 Q&A guidance.
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July 28, 2024
Artificial Intelligence
FDAcop
