FDA’s Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021

The U.S. Food and Drug Administration (FDA) recently published the draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, Guidance for Industry. Comments can be submitted to FDA by January 19, 2021.

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