Interchangeable biosimilars

20
Nov

New Draft FDA Guidance on BLAs for Biosimilars and Interchangeable Biologics

The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products.  This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]

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