Analytics that Matter: How LC and MALS Drive Biosimilar Success

The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data.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.