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US FDA May Be Shifting Its Thinking On Biosimilar Trials

 
• By Dave Wallace

Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.

Two recent examples are seen of fresh thinking from the FDA on biosimilar development. (Shutterstock)

The US Food and Drug Administration is increasingly open to approving biosimilar filings without full Phase III clinical trial data.

Two recent company disclosures revealed agency scientific advice indicating applications could be approved without the usual suite of supporting trials.

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