New FDA Approval: Jubbonti (denosumab) Summary
The Food and Drug Administration (FDA) recently approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab).
Read the InpharmD summary below:
| Drug Name |
Jubbonti (denosumab-bbdz) Injection |
| Active Ingredient |
denosumab-bbdz (Prolia) |
| Date of Approval |
3/5/2024 |
| Manufacturer |
Sandoz Inc. |
| Approval Pathways |
BLA |
| Therapeutic Class |
Bone Resorption Inhibitor |
| Formulation |
Injection |
| MoA |
Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab products prevent RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. |
| Dosing and Administration |
Injection: Single-dose prefilled syringe containing 60 mg in a 1 mL solution.
Jubbonti should be administered by a healthcare professional.
• Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
• Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. |
| Place in Therapy |
The FDA approved denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) as the first and only FDA-approved denosumab (Xgeva and Prolia; Amgen) biosimilars to treat all indications of the reference products Xgeva and Prolia.
For the treatment of postmenopausal women with osteoporosis at high risk for fracture; increasing bone mass in men with osteoporosis at high risk for fracture; glucocorticoid-induced osteoporosis in men and women at high risk for fracture; increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
|
| Expected Market Launch Date |
Expected launch date unavailable. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation/Biosimilar |
| Expected Cost |
Estimation unavailable |
| Product Discontinuation |
N/A |
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