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
FDANov 2025approved
EMAnot listed
CDSCOSep 2013permitted
EDEnot listed
Status by market
FDA
United States · Armlupeg
US Food and Drug AdministrationApprovedBrand
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
Presentations
6 mg/0.6 mL PFS
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2013CDSCO permission granted
- FDANov 2025Approved by FDA as Armlupeg
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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