Biogenomics insulin aspart
Insulin aspart biosimilar developed by Biogenomics. Reference product NovoRapid (NovoLog in the United States).
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Biogenomics · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOOct 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Biogenomics insulin aspart
Biogenomics received the first Indian permission for a domestically made insulin aspart, in October 2021, and added a premixed 30/70 version in 2025. Biogenomics is a Mumbai insulin specialist and this is its main product.
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
Biogenomics Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2021
Application or permission
MF/BIO/21/000120; drug substance MF/BULK/BD/312/2021; biphasic 30/70 MF/BIO/25/000127 (August 2025)
Indications as licensed
Diabetes mellitus in adults; biphasic premix for adults from 30 years (2025)
Presentations
100 U/mL solution; biphasic 30/70 100 IU/mL in 3 mL cartridge (2025)
Remarks
First domestic insulin aspart permitted in India.
Source
S011 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Biogenomics insulin aspart holds an approval, these are the other insulin aspart biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 1 | Sanofi (Merilog / Insulin aspart Sanofi) |
Chronology
- CDSCOOct 2021CDSCO permission granted
Sources
Planning insulin aspart 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.