BLA 761392, held by Samsung Bioepis Co Ltd. Denosumab-Dssb.
As of Nov 13, 2026, BLA 761392 (Ospomyv, Xbryk, Denosumab-Dssb), held by Samsung Bioepis Co Ltd, was first approved by FDA on Oct 29, 2025, with 0 approved supplements and 0 published complete response letters.
Ospomyv 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 of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2025 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ospomyv60MG/ML · injectable;subcutaneous | Denosumab-Dssb | Rx |
| Xbryk70MG/ML · injectable;subcutaneous | Denosumab-Dssb | Rx |
| Denosumab-Dssb60MG/ML · injectable;subcutaneous | Denosumab-Dssb | Rx |
| Denosumab-Dssb70MG/ML · injectable;subcutaneous | Denosumab-Dssb | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
