FDA strengthens the role of analytical comparability in biosimilar development
Analytical Comparability at the Center of Modern Biosimilar Development The U.S. Food and Drug Administration (FDA) has recently updated its guidance with a set of new and revised draft Q&As on Biosimilar Development [1]. A key focus of this update is the clarification of conditions under which a non‑U.S. authorized reference product may be used […]
FDA – Waives Clinical Efficacy Studies
A New Era for Biosimilars: Powered by Analytics In a historic regulatory shift, the U.S. FDA has reportedly accepted the first application for a biosimilar monoclonal antibody without requiring a comparative clinical efficacy study. This landmark decision signals the beginning of a new era in biosimilar development, where scientific rigor and affordability converge. It also […]
A holistic analysis platform for assessing protein modification and functional activity
Linking Protein Modifications to Functional Impact. Protein modifications are critical for the efficacy, safety, and stability of therapeutic antibodies. Here, we introduce a comprehensive analysis platform tailored to assess post-translational modifications of therapeutic proteins hand in hand with their functional activity. In the present approach, we successfully applied peptide mapping with LC-ESI-MS to determine deamidation […]