Ponlimsi (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Teva GmbH
- Status
- Authorised
- Therapeutic area
- Bone Resorption; Osteoporosis; Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 17 Nov 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006238
- 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 Ponlimsi 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, Ponlimsi 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
FDA approves biosimilar Ponlimsi (denosumab-adet)
Teva Pharmaceuticals, Inc.; BLA761385; Biosimilar; injectable · source
Ponlimsi (denosumab) approved in the EU
Marketing authorisation to Teva GmbH; Biosimilar, Additional monitoring · source
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
Follow Ponlimsi
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.