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Lupin insulin glargine

Insulin glargine biosimilar developed by Lupin. Reference product Lantus.

Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Lupin (import) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2015permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Lupin insulin glargine

Lupin has held an Indian import permission for insulin glargine since 2015, in vials and cartridges. Lupin later took its own etanercept and ranibizumab to Western markets, but its insulin glargine is an imported product for India.

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 OrganisationApproved
Brand
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 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Lupin insulin glargine holds an approval, these are the other insulin glargine biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO9Biocon Biologics (Semglee), Cipla (Cipla insulin glargine), Eli Lilly (Rezvoglar / Abasaglar), Eris Lifesciences (Eris insulin glargine), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Regenix (Regenix insulin glargine), Wockhardt (Wockhardt insulin glargine)

Same developer, other molecules

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

Chronology

Sources

All insulin glargine biosimilars

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.

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Data current to September 2026.