Polpharma Biologics S.A. has announced a global licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab. The agreement excludes the Middle East and North Africa. Vedolizumab, marketed as Entyvio, is a treatment for moderate to severe ulcerative colitis and Crohn’s disease. Under the terms of the deal, Polpharma Biologics will manage the development and production of PB016, while Fresenius Kabi will hold exclusive global commercialization rights outside the Middle East and North Africa.
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Konstantin Matentzoglu, a member of the Supervisory Board of Polpharma Biologics Group, said, “This partnership supports our goal to increase access to high-quality biologics that improve patient outcomes worldwide. Fresenius Kabi’s strong experience in commercialization and their commitment to biosimilars make them a great partner for bringing PB016 to patients. Together, we are making a meaningful step toward tackling the growing need for treatments for chronic inflammatory diseases.” This collaboration builds on Polpharma Biologics’ expanding biosimilar portfolio and proven global development capabilities.
Polpharma Biologics has a strong track record of introducing biosimilars like ranibizumab and natalizumab to the market in partnership with leading pharmaceutical companies. The alliance with Fresenius Kabi reinforces both companies’ dedication to making biologic therapies more affordable while supporting sustainable healthcare systems globally. The partnership emphasizes their shared mission to improve access to advanced treatments and strengthen healthcare infrastructures.
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Polpharma Biologics is an international biotechnology company based in the European Union with integrated operations. The company focuses on developing and manufacturing biosimilars using patented technology and advanced platforms. Their process begins with cell line development and extends through clinical trials to commercial-scale production. With a cell line development center in the Netherlands and two facilities in Poland, Polpharma Biologics provides career opportunities for biotechnology professionals and is well-positioned to meet growing demand for biosimilars across major therapeutic areas, expanding affordable access to effective treatments worldwide.
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