Polpharma Biologics International AG 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."

PB016, a proposed biosimilar to vedolizumab - an integrin receptor antagonist - is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, delivered in a lyophilized vial for intravenous administration. The new candidate was developed by Polpharma Biologics and will also be manufactured by the company. Fresenius Kabi holds exclusive commercialization rights to PB016 globally, excluding the Middle East and North Africa, pending regulatory approvals.

The biosimilar development program was designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, and clinical studies, conducted in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).^1,2

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe, with cases continuing to rise every year across the world.^3,4 IBD is a chronic, progressive condition with no definitive cure, and can have a significant, long-term impact on patients' quality of life. In this context, biosimilars have significant potential to expand access to effective biologic therapies.