Bilprevda FDA Approval History
FDA Approved: Yes (First approved August 29, 2025)
Brand name: Bilprevda
Generic name: denosumab-nxxp
Dosage form: Injection
Company: Shanghai Henlius Biotech, Inc. and Organon
Bilprevda (denosumab-nxxp) 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.
- Bilprevda 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. - Bilprevda is biosimilar to Xgeva and does not have an interchangeability designation.
- Bilprevda is administered via subcutaneous injection.
- FDA approval of Bilprevda was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that Bilprevda was highly similar to and had no clinically meaningful differences to the reference product Xgeva, in terms of safety, purity, and potency.
- Warnings and precautions associated with Bilprevda 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. - Bilprevda is the fifth FDA-approved biosimilar to Xgeva (denosumab) after the approvals of Bomyntra (denosumab-bnht), Osenvelt (denosumab-bmwo) and Xbryk (denosumab-dssb) in 2025, and Wyost (denosumab-bbdz) in 2024.
- Bildyos (denosumab-nxxp) was also approved on August 29, 2025 as the fifth biosimilar to Prolia after the approvals of Conexxence (denosumab-bnht), Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
Development timeline for Bilprevda
| Date | Article |
|---|---|
| Sep 2, 2025 | Approval FDA Approves Bilprevda (denosumab-nxxp), a Biosimilar to Xgeva |
Further information
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