Polpharma Biologics has entered into a global licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab (reference product: Entyvio), targeting patients with moderate-to-severe ulcerative colitis and Crohn's disease. The partnership covers worldwide markets excluding the Middle East and North Africa regions.
Strategic Partnership Structure
Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing activities for PB016, while Fresenius Kabi will hold exclusive commercialization rights. This division of responsibilities leverages each company's core strengths in biosimilar development and global market access.
"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. "Fresenius Kabi's deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide."
Expanding Biosimilar Portfolio
PB016 represents an addition to Polpharma Biologics' growing biosimilar portfolio, which includes ranibizumab and natalizumab. The company has previously brought forward multiple biosimilars across global markets in partnership with leading pharmaceutical companies. Polpharma Biologics develops and manufactures biosimilars using both microbial and mammalian expression systems.
The company operates with integrated capabilities across the European Union, featuring a cell line development center in the Netherlands and two centers of development and manufacturing in Poland. This infrastructure supports programs from cell line development through technical and clinical development to commercial-scale production.
Market Access and Healthcare Impact
The collaboration aims to address the rising burden of chronic inflammatory diseases by expanding global access to affordable biologic medicines while supporting healthcare system sustainability. Fresenius Kabi, as part of the global healthcare group Fresenius, specializes in pharmaceuticals, medical technologies and nutrition products, with presence in over 100 countries and more than 41,000 employees.
Vedolizumab is an integrin receptor antagonist indicated for moderate to severe ulcerative colitis and Crohn's disease. The proposed biosimilar PB016 will require regulatory approval before commercialization, with Fresenius Kabi serving as the marketing authorization holder responsible for compliance with all applicable laws and regulations.
