Zefylti
Filgrastim biosimilar developed by CuraTeQ Biologics (Aurobindo). Reference product Neupogen.
About Zefylti
Zefylti is CuraTeQ's filgrastim, approved in Europe in February 2025, the first European approval for Aurobindo's biologics arm. It was followed within months by CuraTeQ's pegfilgrastim and trastuzumab.
Status by market
United States
Not listed by FDA.
European Union · Zefylti
European Medicines Agency and European CommissionApprovedUnited Kingdom · Zefylti
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 Zefylti holds an approval, these are the other filgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 4 | Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio), Teva (Tevagrastim / Ratiograstim) |
| MHRA | 3 | Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio) |
Same developer, other molecules
Other biosimilars in the Atlas developed by CuraTeQ Biologics: CuraTeQ bevacizumab, Dazublys / CuraTeQ trastuzumab, Dyrupeg / Cavoley.
Chronology
- EMAFeb 2025Authorised by the European Commission as Zefylti
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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