Terrosa / Movymia
Teriparatide biosimilar developed by Richter-Helm BioTec and Gedeon Richter, development code RGB-10. Reference product Forsteo (Forteo in the United States).
About Terrosa / Movymia
Terrosa and Movymia are the same teriparatide, developed by Richter-Helm with Gedeon Richter and approved in Europe in January 2017 as the first teriparatide biosimilars. Richter sells Terrosa and Stada sells Movymia. Because the United States treats teriparatide as a drug, neither has a US biosimilar counterpart.
Status by market
United States
Not listed by FDA.
European Union · Terrosa
European Medicines Agency and European CommissionApprovedEuropean Union · Movymia
European Medicines Agency and European CommissionApprovedUnited Kingdom · Movymia
Medicines and Healthcare products Regulatory AgencyApprovedUnited Kingdom · Terrosa
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Terrosa / Movymia holds an approval, these are the other teriparatide biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 4 | CinnaGen (Zandoriah), Intas Pharmaceuticals (Sondelbay / Intas teriparatide), Not stated in the EMA table (Livogiva), Strides Pharma (Kauliv) |
| MHRA | 6 | Dr. Reddy's Laboratories (Teriparatide Dr. Reddy's), Intas Pharmaceuticals (Sondelbay / Intas teriparatide), Not stated in the MHRA list (Teriparatide Ambio Pharma), Strides Pharma (Kauliv), Sun Pharmaceutical Industries (Teriparatide Sun), Teva (Teriparatide Teva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Gedeon Richter: Enoby / Xtrenbo / Junod / Yaxwer, Tuyory, Usymro.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
Planning teriparatide biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultant