Regulatory Update: The FDA has published a draft guidance containing Additional Q&As on Biosimilar Development and the BPCI Act

November, 24 2020


The FDA has published a draft guidance containing Additional Q&As  on Biosimilar Development and the BPCI Act, which after finalization, will be added as a revision to final  Q&As on biosimilar development. Four Q&As (I.25 to I.28) have been added to provide clarity regarding the submission & labelling requirements of interchangeable biosimilar products.

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