Bosaya FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2025.
FDA Approved: Yes (First approved September 16, 2025)
Brand name: Bosaya
Generic name: denosumab-kyqq
Dosage form: Injection
Company: Biocon Biologics Ltd.
Treatment for: Osteoporosis
Bosaya (denosumab-kyqq) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
- Bosaya is indicated for:
- treatment of postmenopausal women with osteoporosis at high risk for fracture.
- treatment to increase bone mass in men with osteoporosis at high risk for fracture.
- treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
- treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
- treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. - Bosaya is biosimilar to Prolia and does not have an interchangeability designation. The U.S. Food and Drug Administration (FDA) has granted Bosaya provisional interchangeability designation.
- Bosaya is administered via subcutaneous injection.
- FDA approval was based on clinical data showed that Bosaya demonstrated comparable quality, safety, and efficacy to the reference product.
- Bosaya comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Bosaya include hypocalcemia, hypersensitivity reactions, osteonecrosis of the jaw, atypical femoral fractures, multiple vertebral fractures following treatment discontinuation, serious infections including skin infections, dermatologic reactions, severe musculoskeletal pain, and suppression of bone turnover.
- Common adverse reactions:
- Postmenopausal osteoporosis: Common adverse reactions include back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
- Male osteoporosis: Common adverse reactions include back pain, arthralgia, and nasopharyngitis.
- Glucocorticoid-induced osteoporosis: Common adverse reactions include back pain, hypertension, bronchitis, and headache.
- Bone loss due to hormone ablation for cancer: Common adverse reactions include arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. - Bosaya is the sixth FDA-approved biosimilar to Prolia (denosumab) after the approvals of Bildyos (denosumab-nxxp), Conexxence (denosumab-bnht), Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
- Aukelso (denosumab-kyqq) was also approved on September 16, 2025 as the sixth 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.
Development timeline for Bosaya
| Date | Article |
|---|---|
| Sep 17, 2025 | Approval FDA Approves Bosaya (denosumab-kyqq), a Biosimilar to Prolia |
Further information
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