Fresenius, Polpharma Biologics Ink Deal to Commercialize Vedolizumab Biosimilar

Fresenius Kabi is expanding its biopharmaceutical portfolio through a new global licensing agreement with Polpharma Biologics S.A., securing exclusive rights to commercialize the proposed vedolizumab biosimilar PB016 worldwide, excluding the Middle East and North Africa.

Vedolizumab, marketed under the brand name Entyvio by Takeda, is a biologic therapy used in the treatment of moderately to severely active Crohn’s disease and ulcerative colitis. PB016, Polpharma’s proposed biosimilar, is designed to offer a more accessible alternative for patients suffering from these chronic inflammatory conditions.

“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 of Biopharma at Fresenius Kabi. “This agreement reinforces our strategy to grow our autoimmune biosimilars portfolio and serve patients with chronic diseases worldwide.”

Polpharma Biologics, headquartered in Poland, specializes in the development and manufacturing of biosimilars. The company views the collaboration as a key step in broadening access to biologic therapies globally.

“Fresenius Kabi’s deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients,” said Konstantin Matentzoglu, Delegated Supervisory Board Member of Polpharma Biologics Group.

The deal is part of Fresenius Kabi’s broader #FutureFresenius strategy, which focuses on strengthening its biopharma platform and expanding access to life-saving treatments. The company has recently gained regulatory approvals in the U.S. and Europe for its denosumab and ustekinumab biosimilars, signaling continued momentum in the biosimilars space.

Pending regulatory approval, PB016 could become a key addition to Fresenius Kabi’s growing biosimilars portfolio, helping address the rising global burden of inflammatory bowel diseases.