USV teriparatide
Teriparatide biosimilar developed by USV. Reference product Forsteo (Forteo in the United States).
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: USV · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2012permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About USV teriparatide
USV received its teriparatide permission in India in August 2012, in a vial, with a permission for the drug substance the following month. USV also makes pegfilgrastim and somatropin.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
USV Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2012
Application or permission
MF-179/2012; drug substance Bulk-255/2012 (September 2012)
Indications as licensed
Postmenopausal women with osteoporosis at high risk of fracture
Presentations
750 micrograms in 3 mL vial
Source
S014 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where USV teriparatide holds an approval, these are the other teriparatide biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 3 | Enzene Biosciences (Enzene Biosciences teriparatide), Intas Pharmaceuticals (Sondelbay / Intas teriparatide), Zydus Lifesciences (Zydus teriparatide) |
Same developer, other molecules
Other biosimilars in the Atlas developed by USV: USV pegfilgrastim, USV somatropin.
Chronology
- CDSCOAug 2012CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning teriparatide biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.