Health
US Food and Drug Administration (FDA) Approves Henlius and Organon's BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2
About this update from Organon & Co.
[{"type":"text","content":"SHANGHAI and JERSEY CITY, N.J., Sept. 2, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2","length":446,"tagName":"p"},{"type":"text","content":""The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population.3,4,5 Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women," said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon.3,4 "This approval underscores Organon's unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health."4,5,6","length":686,"tagName":"p"},{"type":"text","content":"BILDYOS is a RANK ligand (RANKL) inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. See full indications below. ","length":589,"tagName":"p"},{"type":"text","content":"Patients with advanced kidney disease treated with BILDYOS are at greater risk of severe hypocalcemia. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported with denosumab products. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment ...