Solumarv
Insulin human biosimilar developed by Marvel Lifesciences. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
Brands by market: Solumarv (EU, refused) · Commercial partner or holder: Marvel Lifesciences · 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 Solumarv
Solumarv was a human insulin filed in Europe by Marvel Lifesciences of the United Kingdom. The committee refused it in November 2015 on manufacturing and quality grounds, the only biosimilar application EMA has refused outright.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Solumarv
European Medicines Agency and European CommissionWithdrawnBrand
Solumarv
Holder or applicant
Marvel Lifesciences Ltd
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/003858
Withdrawn
date not published
Presentations
see SmPC
Remarks
Refused by the CHMP, opinion 19 November 2015.
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
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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