Polpharma Biologics SA, a European-based biotechnology company, has entered into a global licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab (reference product: Entyvio). This biosimilar is intended for the treatment of moderate to severe ulcerative colitis and Crohn’s disease. The agreement covers all global markets excluding the Middle East and North Africa (MENA) region.
Defined Roles: Development by Polpharma, Commercialization by Fresenius Kabi
Under the terms of the deal, Polpharma Biologics will oversee the development and manufacturing of PB016. Meanwhile, Fresenius Kabi will hold exclusive global commercialization rights, outside of MENA. This partnership aims to leverage each company’s core strengths—Polpharma’s proven development capabilities and Fresenius Kabi’s extensive commercial reach.
Shared Mission: Expanding Access to Biologics
“This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,” said Konstantin Matentzoglu, Supervisory Board Member, Polpharma Biologics Group. He added, “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.”
Building on a Strong Biosimilar Track Record
The PB016 agreement strengthens Polpharma Biologics’ expanding biosimilar portfolio. The company has successfully developed and launched multiple biosimilars, including those for ranibizumab and natalizumab, in collaboration with leading global pharma partners.
Commitment to Sustainable and Affordable Healthcare
This strategic alliance reflects both companies’ dedication to improving access to affordable biologic medicines. It also supports the sustainability of healthcare systems worldwide.
About the Partners
Polpharma Biologics is an innovative biotechnology company with fully integrated operations in the European Union. It develops and manufactures biosimilar medicines using patented technologies and advanced platforms, targeting major therapeutic areas. As reported by pharmabiz.com, Fresenius Kabi, part of the global healthcare group Fresenius, focuses on (bio)pharmaceuticals, medical technologies, and nutrition. Serving patients in over 100 countries, the company delivers essential therapies and technologies for the treatment of critically and chronically ill individuals. With a workforce of over 41,000 employees, Fresenius Kabi continues to expand its mission of delivering life-saving healthcare solutions globally.