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) ยท Commercial partner or holder: Biogenomics
FDAnot listed
EMAnot listed
CDSCOOct 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
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)
Note
First domestic insulin aspart permitted in India.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2021CDSCO permission granted
Sources
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