Terrosa / Movymia
Teriparatide biosimilar developed by Richter-Helm BioTec and Gedeon Richter, development code RGB-10. Reference product Forsteo (Forteo in the United States).
Brands by market: Terrosa and Movymia (EU) · Commercial partner or holder: Gedeon Richter (Terrosa); Stada (Movymia)
FDAnot listed
EMAJan 2017authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Terrosa
European Medicines Agency and European CommissionApprovedBrand
Terrosa
Holder or applicant
Gedeon Richter Plc.
Pathway
Centralised (Article 10(4))
Approved
Jan 2017
Application or permission
EMEA/H/C/003916
Indications as licensed
Osteoporosis in postmenopausal women and men; glucocorticoid-induced osteoporosis
Presentations
see SmPC
Note
First EU teriparatide biosimilar.
Source
S017
EMA
European Union · Movymia
European Medicines Agency and European CommissionApprovedBrand
Movymia
Holder or applicant
STADA Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Jan 2017
Application or permission
EMEA/H/C/004368
Indications as licensed
Osteoporosis in postmenopausal women and men; glucocorticoid-induced osteoporosis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJan 2017Authorised by the European Commission as Terrosa
- EMAJan 2017Authorised by the European Commission as Movymia
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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