FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.
News|Articles|September 15, 2026
Advanced Analytical Strategies for Biosimilar Characterization
Author(s)Waters Corporation
This custom eBook examines how advanced analytical characterization is changing biosimilar development following the FDA's October 2025 draft guidance. It covers modern SEC separations for biosimilar antibodies, LC-MS and MAM workflows for protein characterization and attribute monitoring, and the role of multi-angle light scattering (MALS) in biosimilar approval. A closing Q&A with Matthew A. Lauber, PhD, of Waters Corporation, explores how integrating these complementary techniques builds a more complete, regulatory-ready picture of biosimilarity.
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