Eticovo / Benepali
Etanercept biosimilar developed by Samsung Bioepis, development code SB4. Reference product Enbrel.
Brands by market: Eticovo (USA); Benepali (EU) · Commercial partner or holder: Organon (USA); Biogen (EU)
FDAApr 2019approved
EMAJan 2016authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Eticovo
US Food and Drug AdministrationApprovedBrand
Eticovo
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Apr 2019
Application or permission
761066
Licence type
351(k) interchangeable, designated Jun 2024
Presentations
25 mg/0.5 mL, 50 mg/mL
Note
Not launched in the US.
Source
S001, S016
EMA
European Union · Benepali
European Medicines Agency and European CommissionApprovedBrand
Benepali
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Jan 2016
Application or permission
EMEA/H/C/004007
Indications as licensed
RA, JIA, PsA, axSpA, psoriasis
Presentations
see SmPC
Note
First EU etanercept biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJan 2016Authorised by the European Commission as Benepali
- FDAApr 2019Approved by FDA as Eticovo
- FDAJun 2024Eticovo designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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