Drug intelligence / Profile preview

denosumab-nxxp

Development stage
Approved
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

**Denosumab-nxxp** is a biosimilar to denosumab (Prolia/Xgeva), a fully human monoclonal antibody that inhibits RANK ligand (RANKL), preventing its interaction with RANK on osteoclast precursors and mature osteoclasts to reduce bone resorption. Developed by Shanghai Henlius Biotech and commercialized by Organon, it is administered subcutaneously every 6 months (60 mg/mL) for osteoporosis indications or every 4 weeks (120 mg/1.7 mL) for oncology indications. Primary uses include treatment of postmenopausal osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis, bone loss in non-metastatic breast/prostate cancer, prevention of skeletal-related events in multiple myeloma/bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy refractory to bisphosphonates[2][3][4][5][7][8][12].

Brand names
BildyosBilprevda
Other names
Enzene Denosumabdenosumab biosimilar (Alkem Laboratories)denosumab biosimilar (Enzene Biosciences)
02

Targets

RANKL (Receptor Activator for Nuclear Factor-kappa B Ligand)

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