Livogiva
Teriparatide biosimilar developed by Not stated in the EMA table. Reference product Forsteo (Forteo in the United States).
Brands by market: Livogiva (EU); Qutavina (EU, withdrawn) · Commercial partner or holder: Theramex (Livogiva); EuroGenerics (Qutavina)
FDAnot listed
EMAAug 2020authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Livogiva
European Medicines Agency and European CommissionApprovedBrand
Livogiva
Holder or applicant
Theramex Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Aug 2020
Application or permission
EMEA/H/C/005087
Presentations
see SmPC
Source
S017
EMA
European Union · Qutavina
European Medicines Agency and European CommissionWithdrawnBrand
Qutavina
Holder or applicant
EuroGenerics Holdings B.V.
Pathway
Centralised (Article 10(4))
Approved
Aug 2020
Application or permission
EMEA/H/C/005388
Withdrawn
Nov 2020
Presentations
see SmPC
Note
Duplicate authorisation, withdrawn within three months.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2020Authorised by the European Commission as Livogiva
- EMANov 2020Qutavina authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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