Nyvepria
Pegfilgrastim biosimilar developed by Pfizer (Hospira), development code PF-06881894. Reference product Neulasta.
Brands by market: Nyvepria (USA, EU, UAE) · Commercial partner or holder: Pfizer
FDAJun 2020approved
EMANov 2020authorised
CDSCOnot listed
EDEMay 2024registered
Status by market
FDA
United States · Nyvepria
US Food and Drug AdministrationApprovedBrand
Nyvepria
Holder or applicant
Hospira Inc., a Pfizer Company
Pathway
351(k)
Approved
Jun 2020
Application or permission
761111
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
Source
S001, S016
EMA
European Union · Nyvepria
European Medicines Agency and European CommissionApprovedBrand
Nyvepria
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Nov 2020
Application or permission
EMEA/H/C/005085
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Nyvepria
Emirates Drug EstablishmentRegisteredBrand
Nyvepria
Holder or applicant
Hospira Zagreb d.o.o. (Pfizer) · UAE supplier Gulf Drug LLC
Pathway
Registered medical product
Registered
May 2024
Presentations
6 mg/0.6 mL
Source
S018
Chronology
- FDAJun 2020Approved by FDA as Nyvepria
- EMANov 2020Authorised by the European Commission as Nyvepria
- EDEMay 2024Registered in the UAE as Nyvepria
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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