Aukelso FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2025.
FDA Approved: Yes (First approved September 16, 2025)
Brand name: Aukelso
Generic name: denosumab-kyqq
Dosage form: Injection
Company: Biocon Biologics Ltd.
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy
Aukelso (denosumab-kyqq) 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.
- Aukelso (denosumab-kyqq) 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. - Aukelso is biosimilar to Xgeva and does not have an interchangeability designation. The U.S. Food and Drug Administration (FDA) has granted Aukelso provisional interchangeability designation.
- Aukelso is administered via subcutaneous injection.
- FDA approval was based on clinical data showed that Aukelso demonstrated comparable quality, safety, and efficacy to the reference product.
- Warnings and precautions associated with Aukelso 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. - Aukelso is the sixth FDA-approved biosimilar to Xgeva (denosumab) after the approvals of Bilprevda (denosumab-nxxp), Bomyntra (denosumab-bnht), Osenvelt (denosumab-bmwo) and Xbryk (denosumab-dssb) in 2025, and Wyost (denosumab-bbdz) in 2024.
- Bosaya (denosumab-kyqq) was also approved on September 16, 2025 as the sixth 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 Aukelso
| Date | Article |
|---|---|
| Sep 17, 2025 | Approval FDA Approves Aukelso (denosumab-kyqq), a Biosimilar to Xgeva |
Further information
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