Fresenius Kabi Secures Global Rights to PB016 Vedolizumab Biosimilar from Polpharma Biologics

Fresenius Kabi Secures Global Rights to PB016 Vedolizumab Biosimilar from Polpharma Biologics

(IN BRIEF) Fresenius Kabi has licensed rights from Polpharma Biologics to commercialize the vedolizumab biosimilar candidate PB016 globally—except in the Middle East and North Africa—once approved. Vedolizumab treats Crohn’s disease and ulcerative colitis, and PB016 references Takeda’s Entyvio®. The transaction reinforces Fresenius Kabi’s autoimmune biosimilars lineup and follows its recent regulatory successes with denosumab and ustekinumab biosimilars. This collaboration supports the company’s #FutureFresenius strategy to expand its (Bio)Pharma offerings and make affordable, high-quality therapies available to more patients.

(PRESS RELEASE) BAD HOMBURG, 5-Aug-2025 — /EuropaWire/ — Fresenius Kabi is further growing its biopharma portfolio through a new licensing collaboration with Poland-based Polpharma Biologics S.A. Under this agreement, Fresenius Kabi will hold exclusive global commercialization rights to the vedolizumab biosimilar candidate PB016—excluding the Middle East and North Africa—pending regulatory approvals. Vedolizumab, an integrin receptor antagonist, is indicated for treating moderately to severely active Crohn’s disease and ulcerative colitis, and PB016 references Takeda’s Entyvio®.

As part of the Fresenius Group, Fresenius Kabi delivers (bio)pharmaceuticals, medical technologies, and nutritional solutions for both critical and chronic conditions. Polpharma Biologics specializes in developing and manufacturing high-quality biosimilars.

“Securing the in-license of PB016 marks a pivotal step in our mission to provide patients with affordable, top-tier biosimilar therapies,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “This partnership not only bolsters our autoimmune biosimilars pipeline but also advances our commitment to address unmet needs in chronic inflammatory diseases.”

Konstantin Matentzoglu, Delegated Supervisory Board Member of Polpharma Biologics, added, “By joining forces with Fresenius Kabi—renowned for its commercialization expertise—we are poised to expand access to transformative biologic therapies worldwide. Together, we will tackle the growing global burden of chronic inflammatory disorders.”

This deal builds on Fresenius Kabi’s successful biosimilars track record, including recent FDA and EC approvals for its denosumab and ustekinumab biosimilars. These initiatives align with the #FutureFresenius strategy, which seeks to strengthen the company’s (Bio)Pharma platform and broaden patient access to life-changing medicines.

About Fresenius Kabi
As a global healthcare company, Fresenius Kabi is Committed to Life. 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. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line with the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit <a href=\”http://www.fresenius-kabi.com/\”>www.fresenius-kabi.com</a>.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. 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.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line with the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com.

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email: communication@fresenius-kabi.com

SOURCE: Fresenius Kabi AG