Lupin filgrastim
Filgrastim biosimilar developed by Lupin. Reference product Neupogen.
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Lupin · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOMar 2013permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Lupin filgrastim
Lupin received its filgrastim permission in India in March 2013, in a syringe and a vial. It is one of Lupin's earliest biosimilars.
Status by market
FDA
United States
Not listed by FDA.
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 OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Lupin Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2013
Application or permission
MF-22/2013
Indications as licensed
Prevention of neutropenia in chemotherapy for non-myeloid malignancy
Presentations
300 mcg/0.5 mL PFS; 60 MIU/mL vial
Source
S014 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Lupin filgrastim holds an approval, these are the other filgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 2 | Cadila Pharmaceuticals (Cadila Pharmaceuticals filgrastim), Gennova Biopharmaceuticals (Gennova filgrastim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Lupin: Armlupeg / Lupin pegfilgrastim, Lupin denosumab, Lupin insulin glargine, Nepexto / Fubelv / Lupin etanercept, Ranluspec / Vislyfa.
Chronology
- CDSCOMar 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning filgrastim biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.