Stoboclo FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2025.

FDA Approved: Yes (First approved February 28, 2025)
Brand name: Stoboclo
Generic name: denosumab-bmwo
Dosage form: Injection
Previous Name: CT-P41
Company: Celltrion USA
Treatment for: Osteoporosis

Stoboclo (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

• Stoboclo 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.
• Stoboclo is biosimilar to Prolia and does not have an interchangeability designation.
• Stoboclo is administered via subcutaneous injection.
• FDA approval was based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles.
• Stoboclo comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Stoboclo 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.
• Stoboclo (denosumab-bmwo) is the third FDA-approved biosimilar to Prolia (denosumab) after the approvals of Ospomyv (denosumab-dssb) in 2025 and Jubbonti (denosumab-bbdz) in 2024.
• Osenvelt (denosumab-bmwo) was also approved on February 28, 2025 as the third biosimilar to Xgeva (denosumab) after the approvals of Xbryk (denosumab-dssb) in 2025 and Wyost (denosumab-bbdz) in 2024.

Development timeline for Stoboclo

Further information

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