Lusduna
Insulin glargine biosimilar developed by Merck Sharp & Dohme (with Samsung Bioepis). Reference product Lantus.
Brands by market: Lusduna (EU, withdrawn) · Commercial partner or holder: MSD
FDAnot listed
EMAwithdrawn
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Lusduna
European Medicines Agency and European CommissionWithdrawnBrand
Lusduna
Holder or applicant
Merck Sharp & Dohme B.V.
Pathway
Centralised (Article 10(4))
Approved
Jan 2017
Application or permission
EMEA/H/C/004101
Withdrawn
Oct 2018
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAOct 2018Lusduna authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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