Polpharma Biologics' Vedolizumab Biosimilar Under FDA and EMA Review

Polpharma Biologics' proposed vedolizumab biosimilar, PB016, has been accepted for review by both the U.S. FDA and the European Medicines Agency. This candidate aims to be a biosimilar to Takeda's Entyvio®, treating moderately to severely active ulcerative colitis and Crohn's disease. This regulatory step is crucial for potentially expanding global access to more affordable biologic therapies for these chronic conditions.