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Brands by market: Lusduna (EU, withdrawn) · Commercial partner or holder: MSD · Company profile
FDANot listed
EMAWithdrawn
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Not yet approved in any of the 7 markets
Connections
About Lusduna
Lusduna was an insulin glargine developed by Samsung Bioepis and sold by MSD. It was approved in Europe in 2017 and withdrawn in 2018 after the partners decided not to launch it. It never reached patients.
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Withdrawn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 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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- EMAOct 2018Lusduna authorisation withdrawn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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