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Armlupeg / Lupin pegfilgrastim

Pegfilgrastim biosimilar developed by Lupin. Reference product Neulasta.

Brands by market: Armlupeg (USA); brand not published by CDSCO (India) · Commercial partner or holder: Lupin · Company profile
FDANov 2025approved
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOSep 2013permitted
EDENot listed
Approved or registered in 2 of 7 markets
Connections
PegfilgrastimmoleculeLupindeveloper2 of 7markets0trials behind it5other products, same developer12rival developers in its markets

About Armlupeg / Lupin pegfilgrastim

Lupin's pegfilgrastim was permitted in India in 2013 and reached the United States in November 2025 as Armlupeg, twelve years later. It was the seventh pegfilgrastim biosimilar in the United States and Lupin's first US biosimilar approval, followed within months by its ranibizumab.

Status by market

FDA

United States · Armlupeg

US Food and Drug AdministrationApproved
Brand
Armlupeg
Holder or applicant
Lupin Limited (Biotech Division)
Pathway
351(k)
Approved
Nov 2025
Application or permission
761212
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

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Lupin Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2013
Application or permission
MF-186/2013
Indications as licensed
Neutropenia in cytotoxic chemotherapy for non-myeloid malignancy
Presentations
6 mg/0.6 mL PFS
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA7Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Coherus BioSciences (Udenyca), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Kashiv BioSciences (Fylnetra), Pfizer (Nyvepria), Sandoz (Ziextenzo)
CDSCO5Dr. Reddy's Laboratories (Dr. Reddy's pegfilgrastim), Gennova Biopharmaceuticals (Gennova pegfilgrastim), USV (USV pegfilgrastim), Virchow Biotech (Virchow Biotech pegfilgrastim), Wockhardt (Wockhardt pegfilgrastim)

Same developer, other molecules

Other biosimilars in the Atlas developed by Lupin: Lupin denosumab, Lupin filgrastim, Lupin insulin glargine, Nepexto / Fubelv / Lupin etanercept, Ranluspec / Vislyfa.

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.