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Brands by market: Accofil (EU); Grastofil (EU, withdrawn); Filkri (USA) · Commercial partner or holder: Accord Healthcare (EU); Accord BioPharma (USA)
FDAJan 2026approved
EMASep 2014authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Filkri
US Food and Drug AdministrationApprovedBrand
Filkri
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Jan 2026
Application or permission
761027
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS
Source
S001, S016
EMA
European Union · Grastofil
European Medicines Agency and European CommissionWithdrawnBrand
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Withdrawn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
European Union · Accofil
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2014Authorised by the European Commission as Accofil
- EMAJan 2025Grastofil authorisation withdrawn
- FDAJan 2026Approved by FDA as Filkri
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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