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 […]
Midas Pharma and Biofidus join forces for integrated Biotech Solutions
Biofidus AG is now a member of the Midas group. With the acquisition of Biofidus, a leading provider of structural and functional characterization of biopharmaceuticals, Midas Pharma has taken a major step forward in expanding its portfolio of biopharmaceutical services. With this merger, the companies expand their portfolios of service solutions, offering seamless and modular […]