FDA and EMA Accept Polpharma Biologics' Applications for Vedolizumab Biosimilar Review

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review Polpharma Biologics' Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016. This proposed biosimilar to Takeda's Entyvio (vedolizumab) is intended for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, marking a significant step towards expanding access to affordable biologic medicines.