Ovaleap
Follitropin alfa biosimilar developed by Teva (BioGeneriX), development code XM17. Reference product Gonal-f.
About Ovaleap
Ovaleap was the first follitropin alfa biosimilar approved in Europe, in September 2013, developed by Teva's BioGeneriX unit. The licence is now held by Theramex, a women's health company. It has not been filed in the United States.
Status by market
United States
Not listed by FDA.
European Union · Ovaleap
European Medicines Agency and European CommissionApprovedUnited Kingdom · Ovaleap
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 Ovaleap holds an approval, these are the other follitropin alfa biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 1 | Finox Biotech (Bemfola) |
| MHRA | 1 | Finox Biotech (Bemfola) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Teva: Ponlimsi / Degevma, Ranopto, Teriparatide Teva, Tevagrastim / Ratiograstim.
Chronology
- EMASep 2013Authorised by the European Commission as Ovaleap
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)
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