Bysumlog
Insulin lispro biosimilar developed by Gan & Lee Pharmaceuticals. Reference product Humalog.
Brands by market: Bysumlog (EU) · Commercial partner or holder: Gan & Lee Pharmaceuticals Europe (Sandoz)
FDAnot listed
EMAMay 2026authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Bysumlog
European Medicines Agency and European CommissionApprovedBrand
Bysumlog
Holder or applicant
Gan & Lee Pharmaceuticals Europe GmbH
Pathway
Centralised (Article 10(4))
Approved
May 2026
Application or permission
EMEA/H/C/006158
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMay 2026Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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