Fresenius Kabi has announced that the US 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 the reference product Entyvio (vedolizumab) lyophilised vial for intravenous (IV) administration.

The applications were submitted by Polpharma Biologics SA, with Fresenius Kabi holding exclusive commercialisation rights globally, excluding the Middle East and North Africa, pending regulatory approvals.

Dr. Sang-Jin Pak, President Biopharma, Fresenius Kabi, said, “US FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines. With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”

PB016, in-licensed from Polpharma Biologics S.A.1, is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn’s Disease (CD) in adults.

Inflammatory Bowel Disease (IBD), including CD and UC, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialised countries, IBD incidence continues to rise globally alongside increasing industrialisation. In this context, biosimilars have the potential to expand access to effective biologic therapies.

The submissions for the intravenous presentation are supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval.

Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end-to-end biopharma business, covering the entire value chain—from Research and Development (R&D) to manufacturing and global commercialisation. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high-quality, affordable biologic therapies. The FDA and EMA review acceptances represent the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position.