FDA Approves Denosumab Biosimilars Enoby and Xtrenbo
The Food and Drug Administration has approved Enoby, a biosimilar to Prolia, and Xtrenbo, a biosimilar to Xgeva.
The FDA approved Enoby™ (denosumab-qbde), a biosimilar to Prolia® (denosumab), and Xtrenbo™ (denosumab-qbde), a biosimilar to Xgeva® (denosumab).
Approved Uses for Enoby
- Treat postmenopausal women with osteoporosis at high risk for fracture
- Increase bone mass in men with osteoporosis at high risk for fracture
- Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Author's summary: FDA approves two denosumab biosimilars.