Ziextenzo
Pegfilgrastim biosimilar developed by Sandoz, development code LA-EP2006. Reference product Neulasta.
Brands by market: Ziextenzo (USA, EU, UAE) · Commercial partner or holder: Sandoz
FDANov 2019approved
EMANov 2018authorised
CDSCOnot listed
EDEOct 2020registered
Status by market
FDA
United States · Ziextenzo
US Food and Drug AdministrationApprovedBrand
Ziextenzo
Holder or applicant
Sandoz Inc.
Pathway
351(k)
Approved
Nov 2019
Application or permission
761045
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
Source
S001, S016
EMA
European Union · Ziextenzo
European Medicines Agency and European CommissionApprovedBrand
Ziextenzo
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2018
Application or permission
EMEA/H/C/004802
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Ziextenzo
Emirates Drug EstablishmentRegisteredBrand
Ziextenzo
Holder or applicant
Novartis Pharmaceutical Manufacturing GmbH (Sandoz) · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Oct 2020
Presentations
6 mg/0.6 mL
Source
S018
Chronology
- EMANov 2018Authorised by the European Commission as Ziextenzo
- FDANov 2019Approved by FDA as Ziextenzo
- EDEOct 2020Registered in the UAE as Ziextenzo
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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