Regenix insulin glargine
Insulin glargine biosimilar developed by Regenix Biosciences. Reference product Lantus.
About Regenix insulin glargine
Regenix received its Indian manufacturing permission for insulin glargine in 2025, in vials, cartridges and a pen. It is one of a group of newer Indian companies entering insulin manufacture, and it also holds permissions for human insulin.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Regenix insulin glargine holds an approval, these are the other insulin glargine biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 9 | Biocon Biologics (Semglee), Cipla (Cipla insulin glargine), Eli Lilly (Rezvoglar / Abasaglar), Eris Lifesciences (Eris insulin glargine), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Wockhardt (Wockhardt insulin glargine) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Regenix: Regenix human insulin.
Chronology
- CDSCOJun 2025CDSCO permission granted
Sources
Planning insulin glargine biosimilar development?
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