Shanghai Henlius’ Prolia and Xgeva Biosimilars OK’d

FDA has approved two new denosumab biosimilars from Shanghai Henlius Biotech and Organon, ostensibly expanding patient access to treatments for osteoporosis and cancer-related bone conditions. The products, Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), are said to be highly similar to Amgen’s blockbuster drugs Prolia and Xgeva, respectively.

Bildyos is indicated for several osteoporosis-related uses, including reducing fracture risk in postmenopausal women and men with osteoporosis, treating glucocorticoid-induced osteoporosis, and preventing bone loss associated with prostate or breast cancer therapies. Bilprevda is approved to prevent skeletal complications in patients with multiple myeloma or bone metastases from solid tumors, as well as for giant cell tumor of bone and hypercalcemia of malignancy.

Henlius and Organon entered a licensing and supply agreement in 2022, giving Organon exclusive commercialization rights to the biosimilars outside of China.