Polpharma Biologics, a European biotechnology company, has entered into a global licensing agreement with German multinational healthcare firm Fresenius Kabi for the commercialisation of PB016—a proposed biosimilar to vedolizumab.

Vedolizumab is a biologic therapy used to treat moderate to severe ulcerative colitis and Crohn’s disease.

Under the terms of the agreement, Polpharma Biologics will lead the development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialisation rights worldwide, 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.

“Fresenius Kabi’s deep commercialisation 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.”

This strategic collaboration strengthens both companies’ commitments to expanding global access to affordable biologic medicines while supporting healthcare system sustainability.

“Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.

“The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases,” he added.

PB016 is a proposed biosimilar candidate referencing Takeda’s Entyvio, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease.

Based in Poland, Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies.

A part of the global healthcare company Fresenius, Fresenius Kabi specialises in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions.

Headquartered in Bad Homburg, Germany, Fresenius Kabi has a successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars.