• Fresenius Kabi said the FDA accepted a biologics license application for PB016, a vedolizumab biosimilar to Entyvio, for regulatory review.
• The EMA also validated the marketing authorization application for PB016, an IV formulation supplied as a lyophilized powder in vials.
• Polpharma Biologics filed the applications; Fresenius Kabi holds exclusive global marketing rights outside the Middle East, North Africa.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fresenius SE & Co. KGaA published the original content used to generate this news brief on July 31, 2026, and is solely responsible for the information contained therein.