Bildyos (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Sciencepharma Sp. z o.o
- Status
- Authorised
- Therapeutic area
- Bone Resorption; Osteoporosis, Postmenopausal; Osteoporosis
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006434
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hipfractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased riskof fractures. In men with prostate cancer receiving hormone ablation, denosumabsignificantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients atincreased risk of fracture.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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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.