European Commission Approves Two Denosumab Biosimilars

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

The European Commission has granted marketing authorization to Wyost and Jubbonti, the first and only biosimilars for the reference agents Xgeva and Prolia for denosumab in Europe based on robust development programs.1

Wyost received approval for the treatment of patients with cancer-related bone disease and Jubbonti received approval for patients with osteoporosis. Both agents have the same dosage form, administration route, and dosing regimen and presentation as their respective reference agents.

Sandoz, the developer of the 2 agents, is planning the launch of these products beginning November 2025.

“Primary and secondary bone loss, as well as cancer-related bone events, represent an immense disease burden for patients, the economy, and society as a whole. The approval of the first European denosumab biosimilars is a crucial recognition of the need for increased access to these potentially life-changing medicines and demonstrates our continued commitment to delivering more sustainable treatment options for patients, in Europe and beyond,” Claire D’Abreu-Hayling, chief scientific officer of Sandoz, said in a news release.

Approximately one quarter or 4.2 million cases of newly diagnosed cancers occur in Europe wherein cancer is one of the leading causes of premature death in patients between 30 to 69 years of age. Almost all, but especially breast and prostate cancer, can metastasize to the bone, leading to pain and fractures. Additionally, osteoporosis, which was documented in 32 million people over the age of 50 in Europe in 2019, often goes untreated.

Denosumab, the active ingredient in both biosimilars, is a human monoclonal IgG2 antibody that targets and binds to RANKL with high affinity and specificity, stopping the activation of the RANK receptor on the surface of osteoclast precursors and osteoclasts. By preventing the interaction of RANKL/RANK, osteoclasts cannot form, function, or survive, leading to decreased bone resorption in cortical and trabecular bone.

According to the European Medicines Agency prescribing information, Wyost is indicated for the prevention of skeletal-related events (SREs) including pathological fracture, radiation to bone, and spinal cord compression or surgery to bone in adult patients with advanced malignancies involving bone and for the treatment of adults and skeletally mature adolescents with a giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.2

Jubbonti is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.3

References

  1. Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe. News release. Sandoz. May 22, 2024. Accessed May 22, 2024. https://www.globenewswire.com/news-release/2024/05/22/2886160/0/en/Sandoz-receives-European-Commission-approval-for-Wyost-and-Jubbonti-the-first-and-only-biosimilars-of-denosumab-in-Europe.html
  2. Wyost. Prescribing information. Sandoz; 2024. Accessed May 22, 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/wyost
  3. Jubbonti. Prescribing information. Sandoz; 2024. Accessed May 22, 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti