Polpharma and Fresenius Kabi's Vedolizumab Biosimilar PB016 Clears FDA, EMA Review Acceptance

Regulatory momentum continued to build for biosimilar developers this week as two partner companies, Polpharma Biologics and Fresenius Kabi, announced parallel milestones for the same proposed vedolizumab biosimilar candidate, PB016.

Together, the companies confirmed that both the FDA and EMA have accepted the drug's regulatory applications for review, advancing a biosimilar to one of Takeda's leading inflammatory bowel disease (IBD) biologics toward potential approval in both major markets simultaneously.

Polpharma Secures Regulatory Acceptance for PB016

Polpharma Biologics International AG announced that the FDA and EMA have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed biosimilar to Takeda's reference product Entyvio (vedolizumab) in its lyophilized, intravenous formulation, for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.¹ The company characterized the acceptances as significant milestones in its development program.¹

Anjan Selz, CEO of Polpharma Biologics International AG, said, "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. 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."¹

The parallel announcements from Polpharma and Fresenius Kabi reflect how biosimilar development and commercialization are increasingly split across specialized partners, each advancing the same regulatory milestone from a different corporate vantage point.

Vedolizumab is a monoclonal antibody that selectively targets α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut. PB016 has been studied in a phase 1 trial with healthy volunteers and a Phase 3 trial in ulcerative colitis patients, registered as NCT05771155.¹

Fresenius Kabi Confirms Commercialization Role

Fresenius Kabi, an operating company of Fresenius, separately confirmed the same FDA and EMA acceptances for PB016, framing the milestone as reinforcement of its strategy to expand its autoimmune biosimilars portfolio.² The applications were submitted by Polpharma Biologics, while Fresenius Kabi holds exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval, under a global licensing agreement the two companies first signed in August 2025.²

Dr. Sang-Jin Pak, president Biopharma at Fresenius Kabi, said, "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."²

Fresenius Kabi positioned the acceptances as part of its broader #FutureFresenius strategy, which the company says centers on building a vertically integrated biopharma business spanning research, manufacturing, and global commercialization.²

Biosimilar Competition Builds Ahead of Entyvio's Patent Expiry

IBD, including Crohn's disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5 to 3 million patients in Europe, with cases continuing to rise globally alongside increasing industrialization.¹ ² It remains a chronic, progressive condition with no definitive cure, and biosimilars carry significant potential to expand access to effective biologic therapies in a disease area where treatment costs can be substantial.¹ Takeda's US Entyvio net revenues exceeded $4 billion in 2024, and the drug's original US patent is set to expire in 2026, opening the door to biosimilar entry.³ PB016 is not the first vedolizumab biosimilar to reach regulatory review: Alvotech's AVT16 became the first FDA-accepted vedolizumab biosimilar application in June 2026, though that candidate covers only the intravenous formulation and does not include the subcutaneous autoinjector presentation.³ Both regulatory reviews for PB016 now advance in parallel, giving it a potential path to market in the US and EU around the same general timeframe, contingent on the outcome of each agency's full review.

Regulatory Filing Milestones Signal Growing Biosimilar Pipeline Activity

Though neither review has concluded, the dual BLA and MAA acceptances mark a meaningful step for a biosimilar candidate targeting a complex, large-molecule reference product in a therapeutic area where the reference drug's safety and efficacy profile is well established. The coordinated announcement approach, with the developer and commercial partner each confirming the same milestone from their respective roles, reflects the structured division of labor increasingly common in biosimilar development, where one company handles development and manufacturing while a separate commercial partner manages global market access.

References

1. Polpharma Biologics International AG. Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate. Press release. Published July 31, 2026. Accessed July 31, 2026.
2. Fresenius Kabi. Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate. Press release. Published July 31, 2026. Accessed July 31, 2026.
3. Biosimilars Review & Report. Alvotech Submits First Entyvio Biosimilar Application to FDA. Published June 8, 2026. Accessed July 31, 2026.