Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate

Polpharma Biologics International AG today announces that the U.S. 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 Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines.

"FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said Anjan Selz, CEO of Polpharma Biologics International AG. "PB016 represents the culmination of rigorous development work across our integrated platform - from cell line development through comprehensive clinical studies. We are proud to deliver this important therapeutic option in partnership with Fresenius Kabi, an operating company of Fresenius, whose global commercialization capabilities will ensure patients worldwide gain access to high-quality, affordable treatment for chronic inflammatory diseases."

PB016, a proposed biosimilar to vedolizumab - an integrin receptor antagonist - is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, delivered in a lyophilized vial for intravenous administration. The new candidate was developed by Polpharma Biologics and will also be manufactured by the company. Fresenius Kabi holds exclusive commercialization rights to PB016 globally, excluding the Middle East and North Africa, pending regulatory approvals.

The biosimilar development program was designed to demonstrate high similarity to the reference product through comprehensive analytical, non-clinical, and clinical studies, conducted in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155).^1,2

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe, with cases continuing to rise every year across the world.^3,4IBD is a chronic, progressive condition with no definitive cure, and can have a significant, long-term impact on patients' quality of life. In this context, biosimilars have significant potential to expand access to effective biologic therapies.

About Vedolizumab

Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut.¹

It is used in the treatment of moderately to severely active ulcerative colitis and Crohn's disease, chronic inflammatory diseases that can significantly impact patients' quality of life. Vedolizumab is administered by intravenous infusion.

About Polpharma Biologics International AG

Polpharma Biologics International AG orchestrates the development and commercialization of high-quality biosimilar solutions across key therapeutic areas, including immunology and inflammation, ophthalmology, and hematology. Through close collaboration with trusted CDMOs and commercial partners, Polpharma Biologics delivers end-to-end biosimilar programs designed to ensure efficient progression from concept to launch.

Polpharma Biologics International AG provides integrated program leadership and orchestration across the full biosimilar lifecycle, drawing on deep expertise in program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. With a robust and expanding pipeline spanning multiple programs at various stages of development, the company is committed to accelerating access to high-quality biopharmaceutical therapies worldwide.

Important Note

This press release is for informational purposes only and does not constitute promotional material for PB016. The commercialization of proposed vedolizumab biosimilar PB016 is solely the responsibility of Fresenius Kabi, an operating company of Fresenius, in accordance with all applicable laws and regulations.

References

1.	Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis, 10(12), 1437–44.
2.	ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (UCESIVE). Available at: https://clinicaltrials.gov/study/NCT05771155 [Last accessed: July 2026].
3.	Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al. (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology, 165: 1197–1205.
4.	Kumar A., Yassin N., Marley A. et al. (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic Advances in Gastroenterology, 16, 1-16.

*Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company.

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