Lexology October 31, 2025
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.” The draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, signals that FDA may no longer routinely require comparative efficacy studies (CES) when other evidence provides sufficient assurance of biosimilarity.
The draft guidance follows recent FDA developments in the biosimilar space, which we wrote about here, including the first reported waiver of the CES requirement for a biosimilar version of a complex monoclonal antibody biological product. On that occasion we noted FDA’s “growing confidence in advanced analytical...
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