Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
U.S. FDA and EMA acceptance for review of Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, of intravenous vedolizumab biosimilar candidate, an integrin receptor antagonist.
Vedolizumab targets inflammatory bowel diseases, including moderately to severely active ulcerative colitis and Crohn’s disease in adults.
Acceptance reinforces Fresenius Kabi’s strategy to expand its autoimmune biosimilars portfolio and broaden patient access to biologic medicines.
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.
