Anti-TNFSF11 (Denosumab), Human IgG2 Antibody

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The research-grade biosimilar is a fully human IgG2 monoclonal antibody that specifically targets receptor activator of nuclear factor kappa-B ligand (RANKL), a protein that plays a key role in the formation, function, and survival of osteoclasts. RANKL belongs to the TNF superfamily of ligands. Interaction with the receptor (RANK) expressed on pre-osteoclast and mature osteoclast cells results in the activation, migration, differentiation, and fusion of hematopoietic cells of osteoclast lineage, and promotes bone resorption. By preventing the RANKL-RANK interaction, the antibody inhibits bone resorption and increases bone mass density and strength, thus decreasing the risk of hip, vertebral, and non-vertebral fractures. The original monoclonal antibody received approval from the FDA for the treatment of osteoporosis in postmenopausal women, and to treat patients with bone metastases