New FDA Approval: Wyost (denosumab-bbdz) Summary
The Food and Drug Administration (FDA) recently approved Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab).
Read the InpharmD summary below:
| Drug Name |
Wyost (denosumab-bbdz) Injection |
| Active Ingredient |
denosumab-bbdz (Xgeva) |
| 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: 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
WYOST is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.
• Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
• Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.
• Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.
• Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. |
| 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.
It is approved for the following treatment indications, which are also currently approved for Xgeva: prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
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| Expected Market Launch Date |
Expected launch date unavailable. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation/Biosimilar |
| Expected Cost |
$2500 per vial |
| Product Discontinuation |
N/A |
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