Home/Biosimilar Atlas/Pegfilgrastim/Stimufend

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 · Company profile
FDASep 2022approved
EMAMar 2022authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
PegfilgrastimmoleculeFresenius Kabideveloper2 of 7markets0trials behind it4other products, same developer10rival developers in its markets

About Stimufend

Stimufend is Fresenius Kabi's pegfilgrastim, approved in Europe in March 2022 and in the United States in September. It was Fresenius Kabi's first biosimilar in the United States and opened its US biosimilar business, which now includes adalimumab, tocilizumab and denosumab.

Status by market

FDA

United States · Stimufend

US Food and Drug AdministrationApproved
Brand
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
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 · Stimufend

European Medicines Agency and European CommissionApproved
Brand
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 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Coherus BioSciences (Udenyca), Intas Pharmaceuticals (Pelgraz / Ennumo), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria), Sandoz (Ziextenzo)
EMA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Pfizer (Nyvepria), Sandoz (Ziextenzo)

Same developer, other molecules

Other biosimilars in the Atlas developed by Fresenius Kabi: Conexxence / Bomyntra, Elonox, Idacio, Tyenne.

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.