Jubbonti FDA Approval History
Last updated by Judith Stewart, BPharm on March 12, 2024.
FDA Approved: Yes (First approved March 5, 2024)
Brand name: Jubbonti
Generic name: denosumab-bbdz
Dosage form: Injection
Company: Sandoz
Treatment for: Osteoporosis
Jubbonti (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
- Jubbonti is indicated for:
- treatment of postmenopausal women with osteoporosis at high risk for fracture.
- treatment to increase bone mass in men with osteoporosis at high risk for fracture.
- treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
- treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
- treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. - Jubbonti is a biosimilar to Prolia and has an interchangeability designation.
- Jubbonti is administered via subcutaneous injection.
- The FDA approval of Jubbonti is based on clinical data that demonstrated that Jubbonti is biosimilar to Prolia.
- Warnings and precautions associated with Jubbonti include hypocalcemia, hypersensitivity reactions, osteonecrosis of the jaw, atypical femoral fractures, multiple vertebral fractures following treatment discontinuation, serious infections including skin infections, dermatologic reactions, severe musculoskeletal pain, and suppression of bone turnover.
- Common adverse reactions:
- Postmenopausal osteoporosis: Common adverse reactions include back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
- Male osteoporosis: Common adverse reactions include back pain, arthralgia, and nasopharyngitis.
- Glucocorticoid-induced osteoporosis: Common adverse reactions include back pain, hypertension, bronchitis, and headache.
- Bone loss due to hormone ablation for cancer: Common adverse reactions include arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. - Wyost (denosumab-bbdz) was also approved on March 5, 2024 as an interchangeable biosimilar to Xgeva. Jubbonti and Wyost are the first FDA-approved denosumab biosimilars, used to treat all indications of the reference medicines.
Development timeline for Jubbonti
| Date | Article |
|---|---|
| Mar 5, 2024 | Approval FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia |
Further information
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