Introduction Under the FDA’s Draft Guidance on Comparative Efficacy Studies, prospective biosimilar applicants may be able to avoid routine Phase […]
Introduction Under Section 351(k) of the Public Health Service (PHS) Act, the U.S. Food and Drug Administration (FDA) defines a
Introduction On March 9, 2026, the U.S. Food and Drug Administration (FDA) officially announced the withdrawal of its 2015 biosimilarity
Introduction Statistical Approaches to Analytical Similarity encompass quantitative, risk-based frameworks used by regulatory authorities and biopharmaceutical developers to establish that
Introduction Residual uncertainty in biosimilar development determines the scope of regulatory clinical trials by requiring each successive stage of testing
Introduction Glycan profiling analysis for biosimilar characterization provides valuable insights into how critical N-glycoforms, particularly afucosylation, sialylation, and high mannose
Introduction Higher Order Structure Analysis for Biosimilar Characterization is essential because proteins with identical primary amino acid sequences can adopt
Introduction Intact Mass Analysis for Biosimilar Characterization is a fundamental bioanalytical technique used to determine the total mass of a
Introduction Functional assays for biosimilar characterization are essential for evaluating analytical bioequivalence, biological potency, and mechanism-driven functional comparability between proposed
Introduction Glycosylation Profiling for Biosimilar Characterization establishes the structural, physicochemical, and functional comparability of complex oligosaccharide structures attached to therapeutic
