BLA 761424, held by Accord Biopharma Inc.. denosumab-desu.
As of Nov 13, 2026, BLA 761424 (Osvyrti, Jubereq), held by Accord Biopharma Inc., was first approved by FDA on Oct 29, 2025, with 0 approved supplements and 1 published complete response letter.
OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for: 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 application | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 13, 2025 | BLA 761424Facility Inspections, Product Quality, Risk Evaluation And Mitigation Strategy Requirements | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Osvyrti60MG/ML · injectable;subcutaneous | denosumab-desu | Rx |
| Jubereq120MG/1.7ML · injectable;subcutaneous | denosumab-desu | 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
