FDA and EMA Accept Applications for Polpharma Biologics' Vedolizumab Biosimilar PB016
Saturday, August 01, 2026
Polpharma Biologics has announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review its Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed biosimilar to Takeda's Entyvio (vedolizumab).
PB016 is being developed as an intravenous treatment for adults with moderately to severely active ulcerative colitis and Crohn's disease. The biosimilar is supplied as a lyophilised vial for intravenous administration.
The acceptance of the regulatory submissions marks a significant step in the development of PB016 and supports Polpharma Biologics' strategy to expand access to high-quality, more affordable biosimilar medicines.
PB016 has been developed and will be manufactured by Polpharma Biologics. Under an existing agreement, Fresenius Kabi holds exclusive worldwide commercialisation rights for the product, excluding the Middle East and North Africa, subject to regulatory approvals.
The biosimilar development programme included analytical, non-clinical and clinical studies to demonstrate a high level of similarity to the reference medicine, in line with regulatory requirements. PB016 was evaluated in a Phase 1 study involving healthy volunteers and a Phase 3 clinical trial in patients with ulcerative colitis.
Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, affects an estimated 2.4 million people in the United States and between 2.5 million and 3 million people across Europe. As the number of patients continues to grow worldwide, biosimilar medicines are expected to play an important role in improving access to biologic treatments for chronic inflammatory diseases.
Source: businesswire.com
