Tevagrastim / Ratiograstim
Filgrastim biosimilar developed by Teva (with Ratiopharm), development code XM02. Reference product Neupogen.
Brands by market: Tevagrastim and Ratiograstim (EU); Biograstim and Filgrastim ratiopharm (EU, withdrawn); TevaGrastim (UAE) · Commercial partner or holder: Teva
FDAnot listed
EMASep 2008authorised
CDSCOnot listed
EDEJun 2022registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Tevagrastim
European Medicines Agency and European CommissionApprovedBrand
Tevagrastim
Holder or applicant
Teva GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2008
Application or permission
EMEA/H/C/000827
Indications as licensed
Neutropenia in chemotherapy, PBPC mobilisation, severe chronic neutropenia, HIV neutropenia
Presentations
see SmPC
Note
Among the first G-CSF biosimilars authorised in the EU.
Source
S017
EMA
European Union · Ratiograstim
European Medicines Agency and European CommissionApprovedBrand
Ratiograstim
Holder or applicant
Ratiopharm GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2008
Application or permission
EMEA/H/C/000825
Presentations
see SmPC
Source
S017
EMA
European Union · Biograstim
European Medicines Agency and European CommissionWithdrawnBrand
Biograstim
Holder or applicant
AbZ-Pharma GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2008
Application or permission
EMEA/H/C/000826
Withdrawn
Sep 2015
Presentations
see SmPC
Source
S017
EMA
European Union · Filgrastim ratiopharm
European Medicines Agency and European CommissionWithdrawnBrand
Filgrastim ratiopharm
Holder or applicant
Ratiopharm GmbH
Pathway
Centralised (Article 10(4))
Approved
Sep 2008
Application or permission
EMEA/H/C/000824
Withdrawn
Apr 2011
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · TevaGrastim
Emirates Drug EstablishmentRegisteredBrand
TevaGrastim
Holder or applicant
Teva Pharmaceutical Industries, Israel · UAE supplier City Medical Store
Pathway
Registered medical product
Registered
Jun 2022
Presentations
30 MIU/0.5 mL, 48 MIU/0.8 mL
Source
S018
Chronology
- EMASep 2008Authorised by the European Commission as Ratiograstim
- EMASep 2008Authorised by the European Commission as Tevagrastim
- EMAApr 2011Filgrastim ratiopharm authorisation withdrawn
- EMASep 2015Biograstim authorisation withdrawn
- EDEJun 2022Registered in the UAE as TevaGrastim
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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