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 · Company profile
FDAMar 2015approved
EMAFeb 2009authorised
MHRALicenseddate not shown
PMDAMar 2014approved
HCNot listed
CDSCONot listed
EDEMar 2015registered
Approved or registered in 5 of 7 markets
Connections
About Zarxio / Zarzio
Zarxio is the first biosimilar ever approved in the United States, in March 2015. The same Sandoz filgrastim had been approved in Europe as Zarzio in 2009, where it also carries the name Filgrastim Hexal, and in Japan in 2014. It is registered in the UAE. Zarzio became the most-used filgrastim in Europe within a few years of launch, and Zarxio's US approval opened the biosimilar pathway there.
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
Reference product in the Purple Book
Neupogen
Marketing status (Purple Book)
Prescription; some presentations discontinued
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials
Remarks
First biosimilar approved in the United States under the 351(k) pathway.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Duplicate authorisation of Zarzio.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Zarzio
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Zarzio
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
30 and 48 MU syringes
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Filgrastim BS Sandoz
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Filgrastim BS Sandoz
Holder or applicant
Sandoz K.K.
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2014
Indications as licensed
Neutropenia in chemotherapy, stem cell mobilisation, HIV, MDS, aplastic anaemia, congenital neutropenia
Presentations
75, 150 and 300 microgram syringes
Remarks
Filgrastim Biosimilar 3; discontinued from marketing.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada
Not listed by HC.
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Zarxio / Zarzio holds an approval, these are the other filgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 4 | Intas Pharmaceuticals (Accofil / Filkri), Kashiv BioSciences (Releuko), Pfizer (Nivestym / Nivestim), Tanvex BioPharma (Nypozi) |
| EMA | 4 | CuraTeQ Biologics (Zefylti), Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim), Teva (Tevagrastim / Ratiograstim) |
| MHRA | 3 | CuraTeQ Biologics (Zefylti), Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim) |
| PMDA | 2 | Fuji Pharma (Filgrastim BS F / Mochida), Nippon Kayaku (Filgrastim BS NK) |
| EDE | 1 | Teva (Tevagrastim / Ratiograstim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Sandoz: Binocrit / Epoetin alfa Hexal / Abseamed, Enzeevu / Afqlir, Erelzi, Hyrimoz / Hefiya, Inclunox, Jubbonti / Wyost, Omnitrope, Rixathon / Riximyo, Ziextenzo.
Chronology
- EMAFeb 2009Authorised by the European Commission as Filgrastim Hexal
- EMAFeb 2009Authorised by the European Commission as Zarzio
- PMDAMar 2014Approved by MHLW as Filgrastim BS Sandoz
- 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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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