mAbxience Announces European Commission Approval Of Denosumab Biosimilars

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.