FDA Gains Insight For Biosimilars From Brand Manufacturing Changes
FDA has identified a variety of scientific studies that would be needed to support approval of follow-on biologics based on the agency's experience in reviewing applications for biologics manufacturing changes
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While urging Congress to write legislation that allows FDA to decide which scientific data are needed to approve follow-on biologics, comments from the American Society of Clinical Oncology to a House subcommittee note that clinical trials will be necessary for most FOBs
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.