Home/Biosimilar Atlas/Filgrastim/Accofil / Filkri

Accofil / Filkri

Filgrastim biosimilar developed by Intas Pharmaceuticals (Apotex). Reference product Neupogen.

Brands by market: Accofil (EU); Grastofil (EU, withdrawn); Filkri (USA) · Commercial partner or holder: Accord Healthcare (EU); Accord BioPharma (USA) · Company profile
FDAJan 2026approved
EMASep 2014authorised
MHRALicenseddate not shown
PMDANot listed
HCDec 2015approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
FilgrastimmoleculeIntas Pharmaceuticalsdeveloper4 of 7markets0trials behind it11other products, same developer6rival developers in its markets

About Accofil / Filkri

Intas's filgrastim has been approved in Europe since 2013, first as Grastofil and then as Accofil through Accord, with Grastofil later withdrawn. In Canada it was sold by Apotex as Grastofil. In January 2026 it was approved in the United States as Filkri, the fifth filgrastim biosimilar there and Accord's first US growth factor.

Status by market

FDA

United States · Filkri

US Food and Drug AdministrationApproved
Brand
Filkri
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Jan 2026
Application or permission
761027
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Neupogen
Marketing status (Purple Book)
Prescription, marketed
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Grastofil

European Medicines Agency and European CommissionWithdrawn
Brand
Grastofil
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Oct 2013
Application or permission
EMEA/H/C/002150
Withdrawn
Jan 2025
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
EMA

European Union · Accofil

European Medicines Agency and European CommissionApproved
Brand
Accofil
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Sep 2014
Application or permission
EMEA/H/C/003956
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Accofil

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Accofil
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
12, 30, 48 and 70 MU syringes
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Grastofil

Health CanadaApproved
Brand
Grastofil
Holder or applicant
Apotex INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2015
Application or permission
DIN 02441489, 02454548
Presentations
300, 480 micrograms
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA4Kashiv BioSciences (Releuko), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio), Tanvex BioPharma (Nypozi)
EMA4CuraTeQ Biologics (Zefylti), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio), Teva (Tevagrastim / Ratiograstim)
MHRA3CuraTeQ Biologics (Zefylti), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio)
HC2Pfizer (Nivestym / Nivestim), Tanvex BioPharma (Nypozi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.

Chronology

Sources

All filgrastim biosimilars

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Data current to September 2026.