Stimufend
Pegfilgrastim biosimilar developed by Fresenius Kabi, development code MSB11455. Reference product Neulasta.
Brands by market: Stimufend (USA, EU) · Commercial partner or holder: Fresenius Kabi
FDASep 2022approved
EMAMar 2022authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Stimufend
US Food and Drug AdministrationApprovedBrand
Stimufend
Holder or applicant
Fresenius Kabi USA, LLC
Pathway
351(k)
Approved
Sep 2022
Application or permission
761173
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
Source
S001, S016
EMA
European Union · Stimufend
European Medicines Agency and European CommissionApprovedBrand
Stimufend
Holder or applicant
Fresenius Kabi Deutschland GmbH
Pathway
Centralised (Article 10(4))
Approved
Mar 2022
Application or permission
EMEA/H/C/004780
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMar 2022Authorised by the European Commission as Stimufend
- FDASep 2022Approved by FDA as Stimufend
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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