Denosumab Ascend Biosimilar Wins EU Authorisation for Bone Complications

The Denosumab Ascend biosimilar is now authorised across the European Union. The marketing authorisation became valid throughout the EU on 28 August 2026. The product is highly similar to Xgeva, the reference medicine that is already authorised in the EU.

What the medicine is used for

Denosumab Ascend prevents skeletal-related events in adults with advanced cancer that has spread to the bone. These events include fractures, spinal cord compression, and bone problems that need radiotherapy or surgery. It is also used to treat giant cell tumour of bone in adults and skeletally mature adolescents when the tumour cannot be removed surgically, or when surgery would likely cause severe complications.

The active substance is denosumab, a monoclonal antibody. It binds RANKL, a protein that activates the cells that break down bone tissue. Blocking RANKL reduces bone loss. The medicine is a solution for injection under the skin of the thigh, abdomen or upper arm. For bone complications in cancer, it is given once every 4 weeks. For giant cell tumour of bone, an extra dose is given 1 and 2 weeks after the first dose. Patients should also take calcium and vitamin D supplements.

How the Denosumab Ascend biosimilar case was built

Denosumab Ascend did not need its own efficacy study in cancer. Laboratory work found that its structure, purity and biological activity are highly similar to Xgeva. Studies also showed that it produces similar levels of the active substance in the body.

The clinical comparison came from one study of 504 postmenopausal women with osteoporosis. After a year of treatment, bone mineral density in the spine rose by about 5.4% in women who received Denosumab Ascend and by 5.5% in those who received another denosumab-containing medicine. The EMA considered this sufficient because denosumab works in a similar way in osteoporosis and in the cancer uses. That reasoning is close to the logic behind the biosimilar clinical approach, which tailors the evidence required for a biosimilar rather than repeating full comparative trials every time.

What the authorisation means for patients and payers

The EMA’s view is that, as for Xgeva, the benefits of Denosumab Ascend outweigh the identified risks. For how competition from biosimilars affects patient out-of-pocket costs, see our separate analysis. For the wider picture of EU approvals, see our review of EU medicine authorisations in 2025.

Source: European Medicines Agency, Denosumab Ascend EPAR medicine overview.