Xbryk FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 17, 2025.

FDA Approved: Yes (First approved February 13, 2025)
Brand name: Xbryk
Generic name: denosumab-dssb
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Xbryk (denosumab-dssb) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in 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.

• Xbryk 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.
• Xbryk is biosimilar to Xgeva and does not have an interchangeability designation.
• Xbryk is administered via subcutaneous injection.
• FDA approval of Xbryk was based on totality of evidence including analytical, non-clinical data, and clinical data that demonstrated that Xbryk is biosimilar to Xgeva.
• Warnings and precautions associated with Xbryk 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.
• Xbryk is the second FDA-approved biosimilar to Xgeva (denosumab) after the approval of Wyost (denosumab-bbdz) in 2024.
• Ospomyv (denosumab-dssb) was also approved on February 13, 2025 as the second biosimilar to Prolia (denosumab) after the approval of Jubbonti (denosumab-bbdz) in 2024.

Development timeline for Xbryk

Further information

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