Wyost (denosumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Giant Cell Tumor of Bone; Neoplasms, Bone Tissue
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Fri 17 May 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006378
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Prevention of skeletal related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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.
- 🇺🇸 Denosumab-Dssb Approved · Samsung Bioepis Co Ltd
- 🇪🇺 Denosumab Ascend Authorised · Ascend GmbH
- 🇪🇺 Denbrayce Authorised · Mabxience Research SL
- 🇪🇺 Degevma Authorised · Teva GmbH
- 🇪🇺 Xbonzy Authorised · Reddy Holding GmbH
Follow Wyost
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.