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OSPOMYV (Samsung Bioepis AU Pty Ltd)
Product name
OSPOMYV
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
218 (255 working days)
Active ingredients
Denosumab
Registration type
New biosimilar medicine
Indication
The treatment of osteoporosis in postmenopausal women. Ospomyv significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer
Treatment to increase bone mass in men with osteoporosis at increased risk of fracture.
Treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.