Nivestym / Nivestim
Filgrastim biosimilar developed by Pfizer (Hospira), development code PF-06881893. Reference product Neupogen.
Brands by market: Nivestym (USA); Nivestim (EU) · Commercial partner or holder: Pfizer
FDAJul 2018approved
EMAJun 2010authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Nivestym
US Food and Drug AdministrationApprovedBrand
Nivestym
Holder or applicant
Hospira Inc., a Pfizer Company
Pathway
351(k)
Approved
Jul 2018
Application or permission
761080
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials
Source
S001, S016
EMA
European Union · Nivestim
European Medicines Agency and European CommissionApprovedBrand
Nivestim
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Jun 2010
Application or permission
EMEA/H/C/001142
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2010Authorised by the European Commission as Nivestim
- FDAJul 2018Approved by FDA as Nivestym
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)
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