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EB1001 is a biosimilar monoclonal antibody developed by Eden Biologics (formerly JHL Biotech) that targets the receptor activator of nuclear factor kappa-B ligand (RANKL). It is designed as a biosimilar to the reference product Prolia (denosumab). By binding to RANKL, EB1001 prevents the activation of the RANK receptor on the surface of osteoclasts and their precursors, thereby inhibiting osteoclast formation, function, and survival. This mechanism leads to decreased bone resorption and increased bone mass and strength. EB1001 is primarily being developed for the treatment of postmenopausal osteoporosis and the prevention of bone loss in patients with prostate or breast cancer receiving bone-loss-inducing therapies. The drug has completed Phase 1 pharmacokinetic studies and has entered Phase 3 clinical trials to demonstrate therapeutic equivalence to the reference biologic.
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