Polpharma Biologics, Fresenius Kabi Enter Licensing Agreement for Proposed Biosimilar to Takeda’s Entyvio

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Europe-based Polpharma Biologics announced on Aug. 5, 2025, that it has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, Polpharma Biologics’ proposed biosimilar to vedolizumab (brand name Entyvio) (1), Takeda Pharmaceuticals’ originator biologic for treating ulcerative colitis (UC) and Crohn's disease (CD) that was approved by FDA in May 2014 (2).

Under the licensing agreement, Polpharma Biologics will lead the development and manufacture of PB016, and Fresenius Kabi will hold exclusive worldwide commercialization rights, excluding the Middle East and North Africa.

“This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,” said Konstantin Matentzoglu, supervisory board member of Polpharma Biologics Group, in a company press release (1). “Fresenius Kabi’s deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.”

A growing biosimilar portfolio

This agreement builds on Polpharma Biologics’ growing biosimilar portfolio and development capabilities. The company has previously partnered with major pharmaceutical companies to bring multiple biosimilars—including ranibizumab and natalizumab—to market across global markets.

The reference product for the company’s ranibizumab biosimilar is Lucentis (ranibizumab) by Roche’s Genentech (3). Under the Lucentis brand name, the originator ranibizumab was approved by FDA in June 2006 for treating neovascular (wet) age-related macular degeneration (nAMD) (3). In August 2022, Polpharma Biologics received FDA approval for its biosimilar product, ranibizumab-eqrn (brand name Cimerli), deemed interchangeable with Lucentis (4). The company also received approval from the European Commission (EC) in the same month for its ranibizumab biosimilar under the European brand name Ranivisio (5).

Most recently in April 2025, the company’s Ranivisio-branded ranibizumab biosimilar product was approved in Brazil by the Brazilian Health Regulatory Agency for treating debilitating retinopathies in the country.

The company’s ranibizumab biosimilar belongs to the anti-vascular endothelial growth factor therapy class of biologics, which offer significant benefits in helping to maintain or gain vision. This class of biologics represents an additional treatment option for nAMD, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization (1).

The reference product for the natalizumab biosimilar is Biogen’s Tysabri (natalizumab), approved by FDA in November 2004 for treating relapsing forms of multiple sclerosis (6). Polpharma Biologics received approval for its biosimilar product, Tyruko (natalizumab-sztn), in August 2023 by FDA and in September 2023 by the EC for the same indication (7).

Polpharma Biologics’ programs start with cell line development and transition through technical and clinical development to commercial-scale production. The company’s expertise lies in its development and manufacturing capabilities, which are based on both microbial and mammalian expression systems. The company has a cell line development center in the Netherlands as well as two development and manufacturing centers in Poland.

References

1. Polpharma Biologics. Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016. Press Release. Aug. 5, 2025.
2. FDA. FDA Approves Entyvio to Treat Ulcerative Colitis and Crohn's Disease. Press Release. May 20, 2014.
3. FDA. FDA Approves New Biologic Treatment for Wet Age-Related Macular Degeneration. Press Release. June 30, 2006.
4. Polpharma Biologics. US Food and Drug Administration (FDA) Approves FYB201/CIMERLI (ranibizumab-eqrn), the First and Only Biosimilar Interchangeable with Lucentis. Press Release. Aug. 3, 2022.
5. Polpharma Biologics. FYB201/Ranivisio (Ranivisio – Ranibizumab), a Biosimilar to Lucentis. Press Release. Aug. 29, 2022.
6. FDA. First Monoclonal Antibody Treatment for Multiple Sclerosis Approved. Press Release. Nov. 23, 2004.
7. Polpharma Biologics. Polpharma Biologics Announces Approval of Europe’s First and Only Biosimilar for Multiple Sclerosis—Tyruko (natalizumab). Press Release. Sept. 28, 2023.