EMA — authorised 16 May 2024
- Application: EMEA/H/C/005964
- Marketing authorisation holder: Sandoz GmbH
- Local brand name: Jubbonti
- Indication: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
- Pathway: biosimilar
- Status: approved
On 16 May 2024, the European Medicines Agency (EMA) granted marketing authorisation to Jubbonti, a biosimilar denosumab, for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Jubbonti is also approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The approval is based on the demonstration of biosimilarity to the reference medicine, denosumab.