Eris human insulin
Insulin human biosimilar developed by Eris Lifesciences. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Eris Lifesciences; Eris Bionxt
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCODec 2025permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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/25/000164 to MF/BIO/25/000182 (December 2025); MF/BIO/26/000012 to MF/BIO/26/000047 (2026)
Indications as licensed
Diabetes mellitus requiring injectable insulin
Presentations
Soluble, isophane and biphasic 30/70; 100 IU/mL vials and cartridges
Note
Fourteen permissions across the three presentations, December 2025 to April 2026.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCODec 2025CDSCO permission granted
Sources
Planning insulin human 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.