Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate
Polpharma Biologics International AG today announces 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 Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.
The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines.
"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," said Anjan Selz, CEO of Polpharma Biologics International AG. "PB016 represents the culmination of rigorous development work across our integrated platform - from cell line development through comprehensive clinical studies. We are proud to deliver this important therapeutic option in partnership with Fresenius Kabi, an operating company of Fresenius, whose global commercialization capabilities will ensure patients worldwide gain access to high-quality, affordable treatment for chronic inflammatory diseases."
