AMSTERDAM, ZUG, SWITZERLAND & GDAŃSK, POLAND -- Polpharma Biologics S.A. (“Polpharma Biologics”) announced a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn’s disease.

Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & 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 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.”

The agreement builds on Polpharma Biologics’ growing biosimilar portfolio and proven development capabilities. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies.

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

*Entyvio® is a registered trademark of Takeda.