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 · Company profile

FDANov 2019approved

EMANov 2018authorised

MHRALicenseddate not shown

PMDANot listed

HCApr 2020approved

CDSCONot listed

EDEOct 2020registered

Approved or registered in 5 of 7 markets

Connections

Pegfilgrastimmolecule Sandozdeveloper 5 of 7markets 1trial behind it 9other products, same developer 11rival developers in its markets

About Ziextenzo

Ziextenzo is Sandoz's pegfilgrastim, approved in Europe in 2018, in the United States in 2019 and in Canada in 2020, and registered in the UAE. It came to market later than Sandoz had planned after an earlier US application was turned down on manufacturing grounds, an episode that showed how demanding the pegylated molecule is to copy.

Status by market

FDA

United States · Ziextenzo

US Food and Drug AdministrationApproved

Brand

Ziextenzo

Holder or applicant

Sandoz Inc.

Pathway

351(k)

Approved

Nov 2019

Application or permission

761045

Licence type

351(k) biosimilar, not interchangeable

Reference product in the Purple Book

Neulasta

Marketing status (Purple Book)

Prescription, marketed

Presentations

6 mg/0.6 mL PFS

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Ziextenzo

European Medicines Agency and European CommissionApproved

Brand

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 (EMA) · checked Sep 2026

MHRA

United Kingdom · Ziextenzo

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Ziextenzo

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

6 mg syringe

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Ziextenzo

Health CanadaApproved

Brand

Ziextenzo

Holder or applicant

Sandoz Canada Incorporated

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Apr 2020

Application or permission

DIN 02497395

Presentations

6 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Ziextenzo

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Ziextenzo by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
LA-EP2006	Sandoz	Neulasta	Phase 3	Comparative efficacy	Completed	Jun 2012	May 2013	NCT01735175

Other developers in the same markets

Where Ziextenzo holds an approval, these are the other pegfilgrastim biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	7	Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Coherus BioSciences (Udenyca), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria)
EMA	7	Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Pfizer (Nyvepria)
MHRA	5	Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek)
HC	4	Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Intas Pharmaceuticals (Pelgraz / Ennumo), Nora Pharma (Niopeg), Pfizer (Nyvepria)
EDE	3	Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Intas Pharmaceuticals (Pelgraz / Ennumo), Pfizer (Nyvepria)

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, Zarxio / Zarzio.

Chronology

EMANov 2018Authorised by the European Commission as Ziextenzo
FDANov 2019Approved by FDA as Ziextenzo
HCApr 2020Notice of Compliance, Health Canada 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)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All pegfilgrastim biosimilars

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Data current to September 2026.