Lupin insulin glargine
Insulin glargine biosimilar developed by Lupin. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Lupin (import)
FDAnot listed
EMAnot listed
CDSCOFeb 2015permitted
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
Import and marketing permission
Approved
Feb 2015
Application or permission
Import permission
Indications as licensed
Type 1 and type 2 diabetes (adults)
Presentations
100 IU/mL, 10 mL vial and 3 mL cartridge
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2015CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning insulin glargine biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.