Zarxio / Zarzio
Filgrastim biosimilar developed by Sandoz, development code EP2006. Reference product Neupogen.
Brands by market: Zarxio (USA); Zarzio and Filgrastim Hexal (EU); Zarzio (UAE) · Commercial partner or holder: Sandoz
FDAMar 2015approved
EMAFeb 2009authorised
CDSCOnot listed
EDEMar 2015registered
Status by market
FDA
United States · Zarxio
US Food and Drug AdministrationApprovedBrand
Zarxio
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Mar 2015
Application or permission
125553
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials
Note
First biosimilar approved in the United States under the 351(k) pathway.
Source
S001, S016
EMA
European Union · Zarzio
European Medicines Agency and European CommissionApprovedBrand
Zarzio
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Feb 2009
Application or permission
EMEA/H/C/000917
Indications as licensed
Neutropenia in chemotherapy, PBPC mobilisation, severe chronic neutropenia, HIV neutropenia
Presentations
see SmPC
Source
S017
EMA
European Union · Filgrastim Hexal
European Medicines Agency and European CommissionApprovedBrand
Filgrastim Hexal
Holder or applicant
Hexal AG
Pathway
Centralised (Article 10(4))
Approved
Feb 2009
Application or permission
EMEA/H/C/000918
Presentations
see SmPC
Note
Duplicate authorisation of Zarzio.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Zarzio
Emirates Drug EstablishmentRegisteredBrand
Zarzio
Holder or applicant
Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Mar 2015
Presentations
30 MU/0.5 mL, 48 MU/0.5 mL
Source
S018
Chronology
- EMAFeb 2009Authorised by the European Commission as Filgrastim Hexal
- EMAFeb 2009Authorised by the European Commission as Zarzio
- FDAMar 2015Approved by FDA as Zarxio
- EDEMar 2015Registered in the UAE as Zarzio
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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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