Polpharma Biologics Signs Global Licensing Deal with Fresenius Kabi for Vedolizumab Biosimilar

• Polpharma Biologics has signed a global licensing agreement (excluding MENA) with Fresenius Kabi for the commercialisation of PB016, a proposed biosimilar to vedolizumab.

• Under the agreement, Polpharma Biologics will develop and manufacture PB016, while Fresenius Kabi will manage commercialisation.

Polpharma Biologics has entered into a global licensing agreement with Fresenius Kabi for the commercialisation of PB016, a proposed biosimilar to vedolizumab. The agreement excludes the Middle East and North Africa regions.

PB016 is being developed as a biosimilar to vedolizumab, an integrin receptor antagonist used in the treatment of moderate to severe ulcerative colitis and Crohn’s disease. Under the terms of the agreement, Polpharma Biologics will retain responsibility for development and manufacturing, while Fresenius Kabi will handle global commercialisation outside the MENA region.

The partnership aligns with both companies’ aims to improve access to biologic medicines and support healthcare system sustainability. Fresenius Kabi’s role leverages its international commercial capabilities and experience in biosimilars.

“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.

The deal further expands Polpharma Biologics’ biosimilar portfolio, which already includes products such as ranibizumab and natalizumab developed through collaborations with major pharmaceutical firms. The move marks another step in Polpharma Biologics’ strategy to enhance the availability of cost-effective biologic therapies.