SPD8-P

SPD8-P is a biosimilar candidate of denosumab, a fully human monoclonal antibody developed by GlycoNex. It targets and binds with high affinity and specificity to the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). By inhibiting RANKL, SPD8-P prevents the activation of the RANK receptor on the surface of osteoclasts and their precursors, which is essential for osteoclast formation, function, and survival. This inhibition leads to reduced bone resorption and increased bone mass and strength. SPD8-P is currently in Phase 3 clinical development in Japan, where it is being compared to the reference biologic Pralia for the treatment of primary osteoporosis in postmenopausal women.

Other names

denosumab biosimilar