Most Biosimilars Would Need Clinical Trials, ASCO Tells House Panel
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
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Over 23 percent of biologics were subject to post-approval “Dear Doctor” communications or black box warnings during a 12-year period, study finds.
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
Clinical trials would be required for most biosimilars under two approval scenarios that are being developed by the World Health Organization