Biocon human insulin
Insulin human biosimilar developed by Biocon Biologics. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: Biocon Biologics (import from Malaysia)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOFeb 2018permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
Biocon Limited
Pathway
Import and marketing permission
Approved
Feb 2018
Application or permission
Import permission (soluble, isophane and biphasic 30/70)
Indications as licensed
Diabetes mellitus
Presentations
100 IU/mL, 3 mL cartridges
Note
Product manufactured at Biocon's Malaysian site.
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2018CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
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