The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments.
Wyost and Jubbonti are the first biosimilars of reference medicines Xgeva and Prolia to receive approval in Europe.
Wyost is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. It is also intended for the treatment of adult and skeletally mature adolescent patients with giant cell bone tumours.
Sandoz’s Jubbonti can be used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, among other bone loss conditions.
The company plans to launch these products from November 2025.
Wyost and Jubbonti contain denosumab, a human monoclonal antibody that hinders the RANKL/RANK interaction. This mechanism is crucial as it prevents the formation and activity of osteoclasts, cells responsible for bone resorption, thus aiding in the maintenance of bone integrity.
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The EC’s authorisation for Wyost and Jubbonti was based on comprehensive development programmes that demonstrated biosimilarity to their reference medicines.
The biosimilars have been developed to match the original products in terms of dosage form, route of administration, dosing regimen and presentation.
Sandoz chief scientific officer Claire D’Abreu-Hayling stated: “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.”
In March 2024, the US Food and Drug Administration approved Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) as denosumab biosimilars.
