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Zadenvi (denosumab)

Region

🇪🇺 EU

Active substance

denosumab

Company

Zentiva k.s.

Status

Authorised

Therapeutic area

Bone Resorption; Osteoporosis; Osteoporosis, Postmenopausal

CHMP opinion

Fri 25 Apr 2025

EU approval

Thu 26 Jun 2025

Designations

Biosimilar, Additional monitoring

Application

EMEA/H/C/006377

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

• 🇺🇸 Enoby Approved · Hikma Pharmaceuticals Usa Inc
• 🇪🇺 Bildyos Authorised · Sciencepharma Sp. z o.o
• 🇪🇺 Jubereq Authorised · Accord Healthcare S.L.U.
• 🇪🇺 Yaxwer Authorised · Gedeon Richter Plc.
• 🇪🇺 Prolia Authorised · Amgen Europe B.V.
• 🇪🇺 Vevzuo Authorised · Biosimilar Collaborations Ireland Limited
• 🇺🇸 Ponlimsi Approved · Teva Pharmaceuticals, Inc.
• 🇪🇺 Wyost Authorised · Sandoz GmbH
• 🇺🇸 Denosumab-Dssb Approved · Samsung Bioepis Co Ltd
• 🇪🇺 Denosumab Ascend Authorised · Ascend GmbH
• 🇪🇺 Denbrayce Authorised · Mabxience Research SL
• 🇪🇺 Degevma Authorised · Teva GmbH

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.