Denosumab Products and its Biosimilars

Denosumab is a fully human monoclonal antibody against receptor activator of nuclear factor κ-β ligand (RANKL) and inhibits its action on the surface receptors expressed on osteoclasts. This causes reduced osteoclast formation, function and survival, consequently decreasing bone resorption, increasing bone mass, and strengthening both cortical and trabecular bone. The role of excessive RANKL as a contributor to conditions characterized by bone loss or bone destruction has been well studied. A comprehensive clinical development program for denosumab resulted in a robust data set that supported global and regulatory approvals of the RANKL-targeted antibody denosumab in the bone loss and cancer inducted bone destruction settings.