Pelgraz / Ennumo
Pegfilgrastim biosimilar developed by Intas Pharmaceuticals. Reference product Neulasta.
Brands by market: Pelgraz (EU, UAE); Ennumo (USA) · Commercial partner or holder: Accord Healthcare (EU, UAE); Accord BioPharma (USA)
FDAMay 2026approved
EMASep 2018authorised
CDSCOnot listed
EDEDec 2021registered
Status by market
FDA
United States · Ennumo
US Food and Drug AdministrationApprovedBrand
Ennumo
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
May 2026
Application or permission
761147
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
Source
S001, S016
EMA
European Union · Pelgraz
European Medicines Agency and European CommissionApprovedBrand
Pelgraz
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Sep 2018
Application or permission
EMEA/H/C/003961
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
see SmPC
Note
First EU pegfilgrastim biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Pelgraz
Emirates Drug EstablishmentRegisteredBrand
Pelgraz
Holder or applicant
Accord Healthcare Limited, United Kingdom · UAE supplier Dupharm Store
Pathway
Registered medical product
Registered
Dec 2021
Presentations
6 mg/0.6 mL
Source
S018
Chronology
- EMASep 2018Authorised by the European Commission as Pelgraz
- EDEDec 2021Registered in the UAE as Pelgraz
- FDAMay 2026Approved by FDA as Ennumo
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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