Polpharma Biologics and Fresenius Kabi partner to develop treatment for ulcerative colitis and Crohn’s disease
Ella Day | August 5, 2025 | News story | Mergers and Acquisitions | Corporate, Crohn’s disease, Fresenius Kabi, Gastrointestinal tract, Polpharma Biologics, ulcerative colitis
Polpharma Biologics has signed a global licensing agreement with Fresenius Kabi for the commercialisation of PB016, a proposed biosimilar to Entyvio (vedolizumab), for the treatment of moderate-to-severe ulcerative colitis and Crohn’s disease. The deal covers global markets excluding the Middle East and North Africa.
Under the agreement, Polpharma Biologics will oversee development and manufacturing of PB016, while Fresenius Kabi will manage global commercialisation. The move will advance access to affordable biologic therapies for chronic inflammatory conditions, a goal of both of the companies.
“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. “Fresenius Kabi’s deep commercialisation experience and commitment to biosimilars make them an ideal partner.”
PB016 joins Polpharma Biologics’ growing portfolio of biosimilars, which includes ranibizumab and natalizumab. The company develops and manufactures biosimilars using both microbial and mammalian expression systems.
Fresenius Kabi, part of the global healthcare group Fresenius, specialises in pharmaceuticals, medical technologies and nutrition products. Using its extensive global reach, it will support the broad distribution of PB016 upon approval.
Ella Day
5/8/25
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