Regenix human insulin
Insulin human biosimilar developed by Regenix Drugs. 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: Regenix Drugs · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2026permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Regenix human insulin
Regenix received its human insulin permissions in India in April 2026, for the premixed and fast-acting forms, alongside its insulin glargine.
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 OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Regenix Drugs Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Apr 2026
Application or permission
MF/BIO/26/000050 (biphasic); MF/BIO/26/000055 (soluble); drug substance IMP/BIO/26/000051
Indications as licensed
Glycaemic control in diabetes mellitus
Presentations
Biphasic 30/70 and soluble insulin
Source
S011 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Regenix human insulin holds an approval, these are the other insulin human biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 8 | Biocon Biologics (Biocon human insulin), Cadila 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), Sanofi (Shantha human insulin) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Regenix: Regenix insulin glargine.
Chronology
- CDSCOApr 2026CDSCO 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.