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Evfraxy (denosumab)

Region

🇪🇺 EU

Active substance

denosumab

Company

Biosimilar Collaborations Ireland Limited

Status

Authorised

Therapeutic area

Bone Resorption; Osteoporosis; Osteoporosis, Postmenopausal

CHMP opinion

Fri 25 Apr 2025

EU approval

Mon 30 Jun 2025

Designations

Biosimilar, Additional monitoring

Application

EMEA/H/C/006526

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 Evfraxy 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 (see section 5.1). In men with prostate cancer receiving hormone ablation, Evfraxy 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 (see section 5.1).

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.