Bildyos FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 24, 2025.
FDA Approved: Yes (First approved August 29, 2025)
Brand name: Bildyos
Generic name: denosumab-nxxp
Dosage form: Injection
Company: Shanghai Henlius Biotech, Inc. and Organon
Treatment for: Osteoporosis
Bildyos (denosumab-nxxp) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
- Bildyos 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 non-metastatic prostate cancer.
- treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. - Bildyos is biosimilar to Prolia and does not have an interchangeability designation.
- Bildyos is administered via subcutaneous injection.
- FDA approval of Bildyos 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 Bildyos was highly similar to and had no clinically meaningful differences to the reference product Prolia, in terms of safety, purity, and potency.
- Bildyos comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Bildyos 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. - Bildyos is the fifth FDA-approved biosimilar to Prolia (denosumab) after the approvals of Conexxence (denosumab-bnht), Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
- Bilprevda (denosumab-nxxp) was also approved on August 29, 2025 as the fifth 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.
Development timeline for Bildyos
| Date | Article |
|---|---|
| Sep 2, 2025 | Approval FDA Approves Bildyos (denosumab-nxxp), a Biosimilar to Prolia |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.