Polpharma Biologics & Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar

Polpharma Biologics S.A. recently 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.

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

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

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists. Learn more at www.polpharmabiologics.com

As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. For more information, please visit www.fresenius-kabi.com.