Lextemy
Bevacizumab biosimilar developed by Mylan (Viatris). Reference product Avastin.
Brands by market: Lextemy (EU, withdrawn) · Commercial partner or holder: Mylan · Company profile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 Lextemy
Lextemy was a bevacizumab filed in Europe by Mylan. The committee gave a positive opinion in February 2021, but the application was withdrawn before the Commission issued a licence. It never reached the market.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Lextemy
European Medicines Agency and European CommissionWithdrawnBrand
Lextemy
Holder or applicant
Mylan IRE Healthcare Limited
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/005611
Withdrawn
Jun 2021
Presentations
see SmPC
Remarks
Withdrawn after opinion, before authorisation.
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.
Same developer, other molecules
Other biosimilars in the Atlas developed by Viatris: Darbepoetin Alfa BS MYL.
Chronology
- EMAJun 2021Lextemy authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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