Eris insulin glargine
Insulin glargine biosimilar developed by Eris Lifesciences. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Eris Lifesciences; Eris Bionxt
FDAnot listed
EMAnot listed
CDSCODec 2025permitted
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
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
Note
Four permissions, December 2025 and June 2026.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCODec 2025CDSCO permission granted
Sources
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Talk to a biosimilar regulatory consultantData current to September 2026.