Fresenius Kabi and Polpharma Biologics Partner to Commercialize Vedolizumab Biosimilar PB016 Globally

Fresenius and Polpharma Entered a Licensing Contract for the Proposed Vedolizumab Biosimilar PB016

Announcement

Polpharma Biologics SA, a leading biotechnology company, signed a licensing agreement with Fresenius Kabi for marketing PB016 worldwide except North Africa and the Middle East. PB016 is a proposed biosimilar to vedolizumab, which is an integrin receptor antagonist, the reference product Entyvio. It is a therapy for moderate to extreme Crohn’s disease and ulcerative colitis. Fresenius is skilled in nutrition products and medical technologies for complex and chronic conditions.

The company’s technologies, services, and products are used for the care and therapy of complex and chronic patients. Polpharma company seamlessly combines operations in the European Union (EU), developing and manufacturing biosimilar medicines. Both companies have experience in their respective specialized sector. The alliance will utilize enhancements to the Fresenius commercialization model and assist Polpharma in expanding its global biosimilars presence and effectiveness in addressing unmet patient care needs.

This licensing contract will strengthen the partnership and further flourish the massive healthcare market with the proposed vedolizumab biosimilar PB016.

Agreement

The terms and conditions of the agreement state that Polpharma Biologics will operate the development and manufacturing of PB016, whereas Fresenius Kabi will be granted the commercial rights globally, except in North Africa and the Middle East. The agreement has confidently built on Polpharma’s rapidly transitioning biosimilar portfolio and full product development potential. Previously, the company has introduced various biosimilars consisting of natalizumab and ranibizumab in the global markets by partnering with giant pharmaceutical companies. This agreement is a strategic move by both companies.

This valuable partnership will empower both companies' commitment to extend availability to affordable biologic medicines, also contributing to healthcare system sustainability. The commercialization of the PB016, if it successfully reaches the target patients, then it will be a milestone for Polpharma. The excessive solution to chronic inflammatory disease will be a relief to the patient population. This contribution to the healthcare sector is an advancement in the global commercial market and an alternative to chronic conditions.

Views and Statements

Supervisory board member of Polpharma biologics group, Konstantin Matentzoglu, proudly expressed his excitement, saying, “This collaboration reflects our mission to enlarge access to quality biologics to enhance patient outcomes worldwide. Fresenius Kabi’s excellent marketing experience and promise to biosimilars make them a trustworthy partner for our PB016 commercialization globally. We’ll take a crucial step ahead together towards identifying the increasing burden of chronic inflammatory diseases.”