The US FDA has approved denosumab-bmwo biosimilar for preventing skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, as well as for treating adults and skeletally mature adolescents with giant cell tumors of bone or hypercalcemia of malignancy that is refractory to bisphosphonate therapy. Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor that prevents RANKL from activating its receptor (RANK) on the surface of osteoclasts, their precursors, and osteoclast-like giant cells.
Clinical evidence In clinical trials, denosumab-bmwo demonstrated equivalent efficacy, pharmacodynamics, and pharmacokinetics to reference denosumab, with comparable safety and immunogenicity profiles. Reference denosumab has been shown to delay the time to the first skeletal-related event (SRE) in breast cancer or castrate-resistant…
