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denosumab   Click here for help

GtoPdb Ligand ID: 6886

Synonyms: AMG-162 | M05BX04 | Prolia® | Xgeva®
Approved drug
denosumab is an approved drug (FDA and EMA (2010))
Compound class: Antibody
Comment: Denosumab suppresses the activity of RANK ligand (RANKL), which normally promotes bone removal and resorption, but which becomes over active in many bone loss diseases.
Denosumab is produced from CHO cells stably expressing recombinant antibody component proteins [1]. It was the first RANKL inhibitor to be approved by the FDA.

Biosimilars:
NameTrade nameCompanyClinical PhaseIndications
denosumab-bbdz; GP2411Jubbonti® and Rolcya®; Wyost®SandozEMA & FDA (2024-2025)Interchangeable with originator reference products Prolia® and Xgeva® respectively
denosumab-dssb; SB16Ospomyv®; Xbryk®; Obodence®Samsung BioepisEMA & FDA (2025)Referencing originator products Prolia® and Xgeva® respectively
denosumab-bmwo; CT-P41Stoboclo®; Osenvelt®CelltrionFDA & EMA (2025)Referencing originator products Prolia® and Xgeva® respectively
denosumab-bnht; FKS518Conexxence®; Bomyntra®Fresenius Kabi BiopharmaFDA (2025)Interchangeable with originator reference products Prolia® and Xgeva® respectively
denosumab-desuOsvyrti®; Jubereq®Accord HealthcareEMA & FDA (2025)Referencing originator products Prolia® and Xgeva® respectively
denosumab-mobz; MB09Izamby®/Boncresa®; Denbrayce®/Oziltus®mAbxience ResearchEMA & FDA (2025)Referencing originator products Prolia® and Xgeva® respectively
biosimilar denosumabEnwylma®; Zadenvi®ZentivaEMA (2025)Referencing originator products Prolia® and Xgeva® respectively
biosimilar denosumabJunod®; Yaxwer®Gedeon RichterEMA (2025)Referencing originator products Prolia® and Xgeva® respectively
biosimilar denosumab; Bmab1000Evfraxy®; Vevzuo®Biocon Biologics/Biosimilar Collaborations IrelandEMA & UK MHRA (2025)Referencing originator products Prolia® and Xgeva® respectively
denosumab-nxxpBildyos®; Bilprevda®SciencepharmaEMA, FDA & UK MHRA (2025)Referencing originator products Prolia® and Xgeva® respectively
biosimilar denosumabDenosumab IntasIntas PharmaceuticalsEMA (2025)Referencing originator product Prolia®
biosimilar denosumab Osqay®Enzene & Theramex Ireland LimitedEMA (2026)Referencing originator product Prolia®
IUPHAR Pharmacology Education Project (PEP) logo

View more information in the IUPHAR Pharmacology Education Project: denosumab

References
1. Boyle WJ, Martin FH, Corvalan JR, Davis CG. (2008)
Immmunoglobulin which prevents binding of osteoprotegerin ligand (OPGL) to osteoclast differentiation and activation receptor (ODAR) for treatment and prevention of bone, inflammatory, arthritic and autoimmune disorders.
Patent number: US7364736. Assignee: Amgen Inc.. Priority date: 26/06/2001. Publication date: 29/04/2008.
2. Coleman RE. (2006)
Clinical features of metastatic bone disease and risk of skeletal morbidity.
Clin Cancer Res, 12 (20 Pt 2): 6243s-6249s. [PMID:17062708]
3. McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH et al.. (2006)
Denosumab in postmenopausal women with low bone mineral density.
N Engl J Med, 354 (8): 821-31. [PMID:16495394]
4. Stewart AF. (2005)
Clinical practice. Hypercalcemia associated with cancer.
N Engl J Med, 352 (4): 373-9. [PMID:15673803]