Bomyntra FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2025.

FDA Approved: Yes (First approved March 25, 2025)
Brand name: Bomyntra
Generic name: denosumab-bnht
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Bomyntra (denosumab-bnht) 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.

• Bomyntra 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.
• Bomyntra is biosimilar to Xgeva and does not have an interchangeability designation.
• Bomyntra is administered via subcutaneous injection.
• FDA approval was based on comprehensive analytical development and similarity assessment supported by comparative clinical studies.
• Warnings and precautions associated with Bomyntra 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.
• Bomyntra is the fourth FDA-approved biosimilar to Xgeva (denosumab) after the approvals of Osenvelt (denosumab-bmwo) and Xbryk (denosumab-dssb) in 2025, and Wyost (denosumab-bbdz) in 2024.
• Conexxence (denosumab-bnht) was also approved on March 25, 2025 as the fourth biosimilar to Prolia (denosumab) after the approvals of Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.

Development timeline for Bomyntra

Further information

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