Denbrayce: New Denosumab Biosimilar Gains European Approval for Bone Tumors

The European Commission (EC) has officially approved Denbrayce, a biosimilar of denosumab, for the prevention of skeletal-related events in adult patients suffering from advanced malignancies involving the bone and for those with giant cell tumors of the bone. This decision follows a favorable recommendation from the Committee for Medicinal Products for Human Use (CHMP) and marks a significant advancement in the treatment options available for patients with these serious conditions.

Denosumab, originally marketed under the brand name Xgeva, is a humanized monoclonal antibody that inhibits the receptor activator of nuclear factor kappa-B ligand (RANKL). This mechanism is vital as it prevents the formation and function of osteoclasts, the cells responsible for bone resorption. According to Dr. Sarah Johnson, Professor of Oncology at the University of Cambridge, the approval of Denbrayce is a "crucial step in improving patient care for those afflicted with bone-related malignancies."

Jurgen Van Broeck, CEO of mAbxience, the company behind Denbrayce, expressed pride in this development, stating, "This approval is a testament to mAbxience’s dedication to scientific excellence and our commitment to broadening access to essential biologic therapies. We are proud to contribute to reducing the burden of osteoporosis, cancer-related bone conditions, and rare bone diseases in Europe."

The approval comes on the heels of the U.S. Food and Drug Administration’s (FDA) green light for two denosumab biosimilars, denosumab-bmwo (Stobloco) and Osenvelt, which reference Prolia and Xgeva, respectively. These approvals were based on a phase 3 clinical trial that demonstrated the efficacy and safety of the biosimilars, enrolling 479 postmenopausal women with osteoporosis. The study revealed that denosumab-bmwo produced results comparable to the reference drug, with a least squares mean difference in lumbar spine bone mineral density percentage change from baseline to week 52 of –0.139%.

The phase 3 study, which was published in Osteoporosis International in November 2024, indicated that the primary efficacy endpoints were met, thereby supporting the safety and effectiveness of denosumab-bmwo. The double-blind, active-controlled trial assessed various outcomes, including pharmacodynamics, pharmacokinetics, and immunogenicity, confirming that the new biosimilar is a viable alternative to the reference product.

In the context of European healthcare, the approval of Denbrayce is expected to enhance access to treatment for patients who require ongoing management of their bone health due to cancer. According to the World Health Organization (WHO), the burden of skeletal-related events in cancer patients can significantly impact quality of life, emphasizing the need for effective treatment options.

As the landscape of cancer treatment continues to evolve, the introduction of biosimilars like Denbrayce is anticipated to play a pivotal role in improving therapeutic options and outcomes for patients dealing with advanced malignancies. Experts predict that with increased availability of such treatments, healthcare costs may also decline, making these essential therapies more accessible to a broader patient demographic.

In conclusion, the approval of Denbrayce not only signifies an important advancement in oncology but also reflects ongoing efforts to enhance patient care through innovative biologic therapies. With further research and development, the future looks promising for patients requiring effective management of bone-related complications arising from cancer.