Wyost FDA Approval History
Last updated by Judith Stewart, BPharm on March 12, 2024.
FDA Approved: Yes (First approved March 5, 2024)
Brand name: Wyost
Generic name: denosumab-bbdz
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy
Wyost (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Xgeva (denosumab) indicated for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.
- Wyost is indicated for:
- 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.
- treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. - Wyost is a biosimilar to Xgeva and has an interchangeability designation.
- Wyost is administered via subcutaneous injection.
- The FDA approval of Wyost is based on clinical data that demonstrated that Wyost is biosimilar to Xgeva.
- Warnings and precautions associated with Wyost include hypersensitivity reactions, hypocalcemia, osteonecrosis of the jaw, atypical femoral fracture, hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons, and multiple vertebral fractures following treatment discontinuation.
- Common adverse reactions:
- Bone Metastasis from Solid Tumors: Common adverse reactions include fatigue/asthenia, hypophosphatemia, and nausea.
- Multiple Myeloma: Common adverse reactions include diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
- Giant Cell Tumor of Bone: Common adverse reactions include arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
- Hypercalcemia of Malignancy: Common adverse reactions include nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. - Jubbonti (denosumab-bbdz) was also approved on March 5, 2024 as an interchangeable biosimilar to Prolia (denosumab). Wyost and Jubbonti are the first FDA-approved denosumab biosimilars, used to treat all indications of the reference medicines.
Development timeline for Wyost
| Date | Article |
|---|---|
| Mar 5, 2024 | Approval FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
