Regenix insulin glargine
Insulin glargine biosimilar developed by Regenix Biosciences. Reference product Lantus.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Regenix Biosciences
FDAnot listed
EMAnot listed
CDSCOJun 2025permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Regenix Biosciences Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2025
Application or permission
MF/BIO/25/000096
Indications as licensed
Type 2 diabetes
Presentations
100 IU/mL, 10 mL vial, 3 mL cartridge and disposable pen
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2025CDSCO permission granted
Sources
Planning insulin glargine 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.