Osenvelt FDA Approval History

Last updated by Judith Stewart, BPharm on March 1, 2025.

FDA Approved: Yes (First approved February 28, 2025)
Brand name: Osenvelt
Generic name: denosumab-bmwo
Dosage form: Injection
Previous Name: CT-P41
Company: Celltrion USA
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Osenvelt (denosumab-bmwo) 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.

• Osenvelt 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.
• Osenvelt is biosimilar to Xgeva and does not have an interchangeability designation.
• Osenvelt is administered via subcutaneous injection.
• FDA approval was based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles.
• Warnings and precautions associated with Osenvelt 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.
• Osenvelt is the third FDA-approved biosimilar to Xgeva (denosumab) after the approvals of Xbryk (denosumab-dssb) in 2025 and Wyost (denosumab-bbdz) in 2024.
• Stoboclo (denosumab-bmwo) was also approved on February 28, 2025 as the third biosimilar to Prolia (denosumab) after the approvals of Ospomyv (denosumab-dssb) in 2025 and Jubbonti (denosumab-bbdz) in 2024.

Development timeline for Osenvelt

Further information

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