Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar
Fresenius Kabi is expanding its growing biopharma portfolio through a new licensing agreement with Polpharma Biologics S.A. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally (except in the Middle East and North Africa), pending approval by respective health authorities. Vedolizumab is a biologic therapy used to treat Crohn’s disease and ulcerative colitis.
As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. Polpharma Biologics is a developer and manufacturer of biosimilar products based in Poland.
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.
“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.”
“This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,” said Konstantin Matentzoglu, Delegated 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.”
This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. These strategic initiatives are part of the #FutureFresenius strategy, which aims to enhance Fresenius’ (Bio)Pharma platform and ensure the availability of life-changing medicines to more patients around the globe.
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.
*Entyvio® is a registered trademark of Takeda.
