Lupin filgrastim
Filgrastim biosimilar developed by Lupin. Reference product Neupogen.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Lupin
FDAnot listed
EMAnot listed
CDSCOMar 2013permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
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
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2013CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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