Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate

Source Summary

BAD HOMBURG, Germany--(BUSINESS WIRE)-- #CommittedToLife--Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration. The applications wer