Fresenius Kabi has entered a global licensing agreement for the commercialisation of Polpharma Biologics’s vedolizumab biosimilar candidate PB016, except in the Middle East and North Africa.
An integrin receptor antagonist, Vedolizumab is a biologic therapy indicated for the treatment of ulcerative colitis and Crohn’s disease.
Under this agreement, Polpharma Biologics will lead the development and manufacturing of PB016 while Fresenius Kabi will have exclusive commercialisation rights globally, excluding the Middle East and North Africa.
Polpharma Biologics’s PB016 is a proposed biosimilar candidate referencing Takeda’s Entyvio, which is used to treat moderately to severely active ulcerative colitis and Crohn’s disease.
Polpharma Biologics group supervisory board member Konstantin Matentzoglu said: “This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally.”
Matentzoglu further highlighted Fresenius Kabi’s expertise, saying: “Fresenius Kabi’s deep commercialisation 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.”
Fresenius Kabi biopharma president Dr Sang-Jin Pak said: “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.”
The deal is stated to build on Polpharma Biologics’ growing biosimilar portfolio. It has previously brought forward several biosimilars, such as ranibizumab and natalizumab, in collaboration with pharmaceutical entities across global markets.
This strategic alliance aims to enhance global access to affordable biologic medicines and support healthcare system sustainability. The partnership aligns with both companies' commitments to expanding the availability of biologics worldwide.
Last October, Fresenius Kabi and Cellular Origins formed a partnership to advance the field of cell and gene therapy (CGT) by automating the manufacturing process.
