INTP23

INTP23 is a biosimilar version of denosumab, a fully human IgG2 monoclonal antibody that binds and neutralizes receptor activator of nuclear factor kappa-B ligand (RANKL), thereby inhibiting osteoclast formation, function, and survival and reducing bone resorption.[1][9] Developed by Accord BioPharma and its parent company Intas (Intas Pharmaceuticals/Intas Biopharmaceuticals), INTP23 is intended as a biosimilar to Amgen’s Prolia and Xgeva for conditions associated with bone loss and bone metastases, including osteoporosis and certain bone cancers.[1][3][7][9][12] Clinical studies conducted by Intas have demonstrated pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity similarity to reference denosumab in postmenopausal women with osteoporosis, and an abbreviated Biologics License Application (aBLA) for INTP23 has been accepted by the U.S. FDA, with marketing approval and launch timing linked to patent litigation settlements with Amgen.[1][5][6][7][8][12]

Brand names

MAB-22MAB22MAB 22

Other names

MAB-22MAB22MAB 22denosumabProlia