mAbxience Announces European Commission Approval of Denosumab Biosimilars

MADRID, July 2, 2025 /PRNewswire/ -- mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce that the European Commission has granted approval for its denosumab biosimilars Denbrayce® and Izamby®. This approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and represents a major milestone in mAbxience's mission to provide high-quality, accessible, and affordable therapies worldwide.

Denbrayce®, referencing Amgen's Xgeva®, is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone.

Izamby®, referencing Amgen's Prolia®, is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, a condition that causes bones to become weak and more prone to breaking.

"This approval is a testament to mAbxience's dedication to scientific excellence and our commitment to broadening access to essential biologic therapies," said Jurgen Van Broeck, CEO of mAbxience. "We are proud to contribute to reducing the burden of osteoporosis, cancer-related bone conditions, and rare bone diseases in Europe. This milestone brings us one step closer to ensuring that more patients across Europe can benefit from high-quality, affordable treatment options."

Denosumab is a human monoclonal antibody that works by inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL), thereby preventing the development of osteoclasts, the cells responsible for bone breakdown. It is a well-established treatment for osteoporosis, treatment-induced bone loss, bone metastases, and giant cell tumor of bone.

With the approval of these biosimilars mAbxience further demonstrates its expertise in the development and production of biosimilars, reinforcing its contribution to improving patient access to life-changing therapies and supporting the sustainability of healthcare systems across Europe.

This approval marks another important step in mAbxience's mission to provide affordable, accessible and life-changing therapies worldwide. With a robust pipeline and a growing network of partners, mAbxience continues to enhance patient access to advanced treatments while supporting healthcare systems in managing the rising costs of biologic medicines.

About mAbxience

mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn.

Photo: https://mma.prnewswire.com/media/2723650/mAbxience_EMA_Denosumab_Biosimilars.jpg