Grasustek
Pegfilgrastim biosimilar developed by Juta Pharma. Reference product Neulasta.
Brands by market: Grasustek (EU) · Commercial partner or holder: Juta Pharma · Company profile
FDANot listed
EMAJun 2019authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
About Grasustek
Grasustek is Juta Pharma's pegfilgrastim, approved in Europe in June 2019. Juta, a small German company, has not named the developer of the product, and it has not been filed elsewhere.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Grasustek
European Medicines Agency and European CommissionApprovedBrand
Grasustek
Holder or applicant
Juta Pharma GmbH
Pathway
Centralised (Article 10(4))
Approved
Jun 2019
Application or permission
EMEA/H/C/004556
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Grasustek
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Grasustek
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
6 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Grasustek holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 7 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| MHRA | 5 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Intas Pharmaceuticals (Pelgraz / Ennumo), Sandoz (Ziextenzo) |
Chronology
- EMAJun 2019Authorised by the European Commission as Grasustek
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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