Year:
2020
Country:
Australia
Drug:
Teriparatide
Brand:
Terrosa®
Reference Brand:
Forteo®
Manufacturer:
Gedeon Richter Australia Pty Ltd
Regulatory Authority:
TGA (Therapeutic Goods Administration)
Regulatory Status:
Approved as biosimilar
Indications:
Osteoporosis in postmenopausal women, primary osteoporosis in men, glucocorticoid-induced osteoporosis
PBAC Consideration:
Minor submission for PBS listing
Dosage Form:
Injection, 250 micrograms/mL, 2.4 mL multi-dose cartridge
Treatment Duration:
24 months
Comparator:
Forteo®
Economic Analysis:
Cost-minimisation
PBS Usage Estimate:
Year 1: 0.48%, Year 6: 45.02%
Administration:
Terrosa pen device requires assembly; Forteo prefilled pen
Endorsements:
Authority Required (STREAMLINED) listing recommended by PBAC
Clinical Evidence:
PK and Phase III trials confirming biosimilarity
Context:
Regulatory submission detailing clinical, economic, and policy considerations for listing Terrosa® as a biosimilar to Forteo® on the PBS in Australia, including dosage, device differences, cost analysis, and PBAC recommendations.
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