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) · 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 human insulin

Eris Lifesciences and its subsidiary Eris Bionxt received fourteen Indian permissions for human insulin between December 2025 and April 2026, covering the fast, intermediate and premixed forms in vials and cartridges, the broadest recent entry into Indian insulin manufacture.

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/25/000164 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
Remarks
Fourteen permissions across the three presentations, December 2025 to April 2026.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO8Biocon Biologics (Biocon human insulin), Cadila Pharmaceuticals (Cadila Pharmaceuticals human insulin), Epygen Biotech (Epygen human insulin), Gland Pharma (Gland Pharma human insulin), M.J. Biopharm (M.J. Biopharm human insulin), Not stated in the CDSCO list (Lupin human insulin), Regenix (Regenix human insulin), Sanofi (Shantha human insulin)

Same developer, other molecules

Other biosimilars in the Atlas developed by Eris Lifesciences: Eris insulin glargine.

Chronology

Sources

All insulin human biosimilars

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 consultant
Data current to September 2026.