The US Food and Drug Administration is increasingly open to approving biosimilar filings without full Phase III clinical trial data. That is the message conveyed by two recent company disclosures that reveal scientific advice from the FDA over biosimilar applications that the agency says can be approved without the usual suite of supporting trials.
FDA Signals Shift In Thinking On Biosimilar Trials
Agency Moves Towards Streamlined Filings With Advice To Xbrane And Formycon
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate how the US Food and Drug Administration’s thinking is evolving on the necessity of Phase III trials to support biosimilar filings.
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