Fresenius Kabi vedolizumab biosimilar PB016 accepted for FDA, EMA review

• Fresenius Kabi reported FDA acceptance for review of a BLA for PB016, an IV vedolizumab biosimilar to Entyvio.
• EMA accepted the MAA for PB016, supporting a potential EU launch pending regulatory decisions.
• Applications were filed by Polpharma Biologics; Fresenius Kabi holds exclusive commercialization rights globally, excluding the Middle East and North Africa.
• PB016 targets ulcerative colitis and Crohn’s disease, expanding Fresenius’ autoimmune biosimilars portfolio.

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.