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Eris insulin glargine

Insulin glargine biosimilar developed by Eris Lifesciences. Reference product Lantus.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Eris Lifesciences; Eris Bionxt · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCODec 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Eris insulin glargine

Eris Lifesciences and its subsidiary Eris Bionxt received four Indian permissions for insulin glargine between December 2025 and June 2026, covering cartridges, vials of three sizes and a pen. Eris entered biosimilars recently and has moved quickly across the insulin range.

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
Eris Lifesciences Limited; Eris Bionxt Private Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Dec 2025
Application or permission
MF/BIO/25/000177; MF/BIO/25/000168; MF/BIO/26/000086; MF/BIO/26/000087
Indications as licensed
Diabetes mellitus in adults, adolescents and children
Presentations
100 IU/mL, 3 mL cartridge, 3 mL, 5 mL and 10 mL vials, pre-filled pen
Remarks
Four permissions, December 2025 and June 2026.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Eris 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), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin 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 Eris Lifesciences: Eris human insulin.

Chronology

Sources

All insulin glargine biosimilars

Planning insulin glargine biosimilar development?

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Data current to September 2026.