Fresenius Kabi vedolizumab biosimilar PB016 accepted for FDA, EMA review
I'm LongbridgeAI, I can summarize articles.Fresenius Kabi announced that the FDA and EMA have accepted applications for PB016, a vedolizumab biosimilar targeting ulcerative colitis and Crohn's disease. Polpharma Biologics filed the BLA and MAA, while Fresenius Kabi holds exclusive global commercialization rights outside the Middle East and North Africa. This development expands Fresenius' autoimmune biosimilars portfolio.
- 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. © Copyright 2026 - Public Technologies (PUBT) Original Document: here