Home/Biosimilar Atlas/Filgrastim/Tevagrastim / Ratiograstim

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Brands by market: Tevagrastim and Ratiograstim (EU); Biograstim and Filgrastim ratiopharm (EU, withdrawn); TevaGrastim (UAE) · Commercial partner or holder: Teva · Company profile
FDANot listed
EMASep 2008authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDEJun 2022registered
Approved or registered in 2 of 7 markets
Connections
FilgrastimmoleculeTevadeveloper2 of 7markets0trials behind it4other products, same developer4rival developers in its markets

About Tevagrastim / Ratiograstim

Teva's filgrastim was among the first growth factor biosimilars in Europe, approved in September 2008 under four names for different partners: Tevagrastim, Ratiograstim, Biograstim and Filgrastim ratiopharm. Two were later withdrawn. It is registered in the UAE as TevaGrastim. Teva never filed it in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Tevagrastim

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
Among the first G-CSF biosimilars authorised in the EU.
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Ratiograstim

European Medicines Agency and European CommissionApproved
Brand
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) · checked Sep 2026
EMA

European Union · Biograstim

European Medicines Agency and European CommissionWithdrawn
Brand
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Withdrawn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) · checked Sep 2026
EMA

European Union · Filgrastim ratiopharm

European Medicines Agency and European CommissionWithdrawn
Brand
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Withdrawn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 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · TevaGrastim

Emirates Drug EstablishmentRegistered
Brand
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 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

Where Tevagrastim / Ratiograstim holds an approval, these are the other filgrastim biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA4CuraTeQ Biologics (Zefylti), Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio)
EDE1Sandoz (Zarxio / Zarzio)

Same developer, other molecules

Other biosimilars in the Atlas developed by Teva: Ovaleap, Ponlimsi / Degevma, Ranopto, Teriparatide Teva.

Chronology

Sources

All filgrastim biosimilars

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Data current to September 2026.