Denosumab-bnht

Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities. PB016 is a biosimilar candidate to 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 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. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy. *Entyvio® is a registered trademark of Takeda.

July 23, 2025 – Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe. The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone. This milestone marks a significant advancement in Fresenius Kabi’s mission to expand access to high-quality biosimilar therapies. It also reinforces the business’ commitment to strengthening its Biopharma platform, a key pillar of the #FutureFresenius strategy. *Conexxence and *Bomyntra are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.