Polpharma Biologics has announced that the FDA and EMA have accepted for review the BLA and MAA for PB016, a proposed vedolizumab biosimilar to Entyvio for intravenous use in adults with moderately to severely active ulcerative colitis and Crohn’s disease. The FDA and EMA reviews cover PB016 in lyophilised vial form for intravenous administration. The biosimilar was developed and will be manufactured by Polpharma Biologics, while Fresenius Kabi holds exclusive global commercialisation rights excluding the Middle East and North Africa. Anjan Selz, CEO of Polpharma Biologics International AG, said: “FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing. The biosimilar development programme was designed to demonstrate high similarity to the reference product through analytical, non‑clinical and clinical studies.