Home/Biosimilar Atlas/Insulin human/Biocon human insulin

Biocon human insulin

Insulin human biosimilar developed by Biocon Biologics. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).

Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Biocon Biologics (import from Malaysia) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOFeb 2018permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Biocon human insulin

Biocon holds Indian import permissions from 2018 for its human insulin in fast, intermediate and premixed forms, made at its plant in Malaysia. Biocon's original Indian human insulin, Insugen, launched in 2004 and predates the published lists.

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
Biocon Limited
Pathway
Import and marketing permission
Approved
Feb 2018
Application or permission
Import permission (soluble, isophane and biphasic 30/70)
Indications as licensed
Diabetes mellitus
Presentations
100 IU/mL, 3 mL cartridges
Remarks
Product manufactured at Biocon's Malaysian site.
Source
S013 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO8Cadila Pharmaceuticals (Cadila Pharmaceuticals human insulin), Epygen Biotech (Epygen human insulin), Eris Lifesciences (Eris 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 Biocon Biologics: Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Semglee, Yesafili, Yesintek / Usrenty.

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.