The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.
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Learn more about:
The FDA’s 2025 biosimilar guidance and its emphas
is on analytical data over comparative efficacy studies
How LC and MALS provide orthogonal, fit-for-purpose methods to assess critical quality attributes and reduce uncertainty
How integrated workflows with Empower software improve reproducibility, efficiency, and compliance in biosimilar development
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