Osqay (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Theramex Ireland Limited
- Status
- Authorised
- Therapeutic area
- Bone Resorption
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Thu 08 Jan 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006492
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
Osqay (denosumab) approved in the EU
Marketing authorisation to Theramex Ireland Limited; Biosimilar, Additional monitoring · source
Osqay (denosumab): CHMP positive opinion
Theramex Ireland Limited; Biosimilar, Additional monitoring · source
Same substance in other markets
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- 🇺🇸 Denosumab-Dssb Approved · Samsung Bioepis Co Ltd
- 🇪🇺 Denosumab Ascend Authorised · Ascend GmbH
- 🇪🇺 Denbrayce Authorised · Mabxience Research SL
- 🇪🇺 Degevma Authorised · Teva GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.