Enoby FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 30, 2025.
FDA Approved: Yes (First approved September 26, 2025)
Brand name: Enoby
Generic name: denosumab-qbde
Dosage form: Injection
Company: Gedeon Richter plc and Hikma Pharmaceuticals plc
Treatment for: Osteoporosis
Enoby (denosumab-qbde) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
- Enoby 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. - Enoby is biosimilar to Prolia and does not have an interchangeability designation.
- Enoby is administered via subcutaneous injection.
- FDA approval was based on a comprehensive analytical, non-clinical, and clinical data package that demonstrated that Enoby has similar quality, efficacy, safety and immunogenicity as the reference product Prolia.
- Enoby comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Enoby 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. - Enoby is the seventh FDA-approved biosimilar to Prolia (denosumab) after the approvals of Bosaya (denosumab-kyqq), Bildyos (denosumab-nxxp), Conexxence (denosumab-bnht), Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
- Xtrenbo (denosumab-qbde) was also approved on September 26, 2025 as the seventh biosimilar to Xgeva (denosumab) after the approvals of Aukelso (denosumab-kyqq), Bilprevda (denosumab-nxxp), Bomyntra (denosumab-bnht), Osenvelt (denosumab-bmwo) and Xbryk (denosumab-dssb) in 2025, and Wyost (denosumab-bbdz) in 2024.
Development timeline for Enoby
| Date | Article |
|---|---|
| Sep 29, 2025 | Approval FDA Approves Enoby (denosumab-qbde), a Biosimilar to Prolia |
Further information
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