Ospomyv FDA Approval History

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

FDA Approved: Yes (First approved February 13, 2025)
Brand name: Ospomyv
Generic name: denosumab-dssb
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Osteoporosis

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

• Ospomyv 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.
• Ospomyv is biosimilar to Prolia and does not have an interchangeability designation.
• Ospomyv is administered via subcutaneous injection.
• FDA approval of Ospomyv was based on totality of evidence including analytical, non-clinical data, and clinical data that demonstrated that Ospomyv is biosimilar to Prolia.
• Ospomyv comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Ospomyv 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.
• Ospomyv (denosumab-dssb) is the second FDA-approved biosimilar to Prolia (denosumab) after the approval of Jubbonti (denosumab-bbdz) in 2024.
• Xbryk (denosumab-dssb) was also approved on February 13, 2025 as the second biosimilar to Xgeva (denosumab) after the approval of Wyost (denosumab-bbdz) in 2024.
  
  

Development timeline for Ospomyv

Further information

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