Cipla insulin lispro
Insulin lispro biosimilar developed by Not stated in the CDSCO list. Reference product Humalog.
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Cipla (import)
FDAnot listed
EMAnot listed
CDSCOSep 2021permitted
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
Cipla Limited
Pathway
Import and marketing permission
Approved
Sep 2021
Application or permission
IMP/BIO/21/000084 (25/75 premix, September 2021); IMP/BIO/21/000085 (October 2021); IMP/BIO/21/000100 (50/50 premix, December 2021); IMP/BIO/23/000049 (ultra-rapid, April 2023)
Indications as licensed
Diabetes mellitus
Presentations
100 IU/mL cartridge and pen; 200 U/mL pen; 25/75 and 50/50 premixes; ultra-rapid 100 U/mL (2023)
Source
S012
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2021CDSCO permission granted
Sources
S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)
Planning insulin lispro 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.