Insulin lispro Sanofi
Insulin lispro biosimilar developed by Sanofi, development code SAR342434. Reference product Humalog.
Brands by market: Insulin lispro Sanofi (EU); Admelog (USA, approved under 505(b)(2), not a 351(k) biosimilar) · Commercial partner or holder: Sanofi
FDAnot listed
EMAJul 2017authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Insulin lispro Sanofi
European Medicines Agency and European CommissionApprovedBrand
Insulin lispro Sanofi
Holder or applicant
Sanofi Winthrop Industrie
Pathway
Centralised (Article 10(4))
Approved
Jul 2017
Application or permission
EMEA/H/C/004303
Indications as licensed
Diabetes mellitus in adults and children
Presentations
see SmPC
Note
First EU insulin lispro biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJul 2017Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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