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mAbxience's Breakthrough in Denosumab Biosimilars Approval

mAbxience, a prominent biopharmaceutical group primarily owned by Fresenius Kabi and partially by Insud Pharma, has some remarkable news to share. On July 2, 2025, the company announced that the European Commission granted approval for its biosimilars of denosumab, specifically Denbrayce® and Izamby®. This groundbreaking decision follows a favorable recommendation from the Committee for Medicinal Products for Human Use (CHMP), marking an essential milestone in mAbxience's mission to offer high-quality, affordable therapies globally.

Denbrayce®, which is a biosimilar referencing Amgen’s Xgeva®, is prescribed to prevent skeletal-related events in adults suffering from advanced malignant tumors involving bones, as well as for the treatment of adults and adolescents who are skeletally mature and have giant cell tumor of the bone. Similarly, Izamby®, mirroring Amgen’s Prolia®, is directed towards treating osteoporosis in postmenopausal women and men at high risk for fractures, a condition that weakens bones, increasing the chances of breakage.

Jurgen Van Broeck, CEO of mAbxience, expressed pride in the achievement, stating, “This approval showcases our dedication to scientific excellence and our commitment to expanding access to vital biologic therapies. We are proud to contribute to minimizing the burden of osteoporosis, cancer-related bone diseases, and rare bone disorders in Europe. This step brings us closer to our goal of ensuring more patients across Europe can benefit from high-quality, affordable treatment options.”

Denosumab is a human monoclonal antibody that inhibits the receptor activator of nuclear factor kappa-B ligand (RANKL), thereby preventing the development of osteoclasts, which are the cells responsible for bone degradation. This treatment is well-recognized for addressing osteoporosis, treatment-induced bone loss, bone metastases, and giant cell tumor of the bone.

With the approval of these biosimilars, mAbxience reaffirms its competence in developing and producing biosimilars while reinforcing its role in enhancing patient access to life-changing therapies and supporting the sustainability of healthcare systems throughout Europe.

This achievement signifies another critical advancement in mAbxience's broader mission to deliver affordable and accessible therapies that improve lives across various regions. With a robust pipeline and an increasing network of partners, mAbxience remains dedicated to optimizing patient access to advanced treatments while contributing to the management of the escalating costs associated with biologic medications.

About mAbxience

mAbxience specializes in the development, production, and commercialization of biopharmaceutical products. In August 2022, a significant milestone was reached when Fresenius Kabi acquired a controlling stake in mAbxience, furthering its status as a vertically integrated global biotechnology company. With over ten years of experience, the company's mission is distinct: to provide accessible and affordable medicines worldwide, enhancing quality of life through universal access to high-quality drugs. Currently, mAbxience has two market-approved products and a solid pipeline in development, establishing B2B relations in over 100 markets. The company has built a network with over 30 partners and employs a dedicated team of more than 1,000 professionals.

mAbxience operates three multiproduct European and South American manufacturing facilities that are approved by regulatory authorities, including the FDA and EMA. As a global biopharmaceutical expert, mAbxience also excels in contract development and manufacturing organization (CDMO) services, utilizing advanced technology and innovative platforms to provide integrated manufacturing solutions. For additional information on mAbxience, its biosimilars, and CDMO activities, please visit www.mabxience.com or connect on LinkedIn.