Home/Biosimilar Atlas/Etanercept/Eticovo / Benepali

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) · Company profile
FDAApr 2019approved
EMAJan 2016authorised
MHRALicenseddate not shown
PMDANot listed
HCAug 2016approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
EtanerceptmoleculeSamsung Bioepisdeveloper4 of 7markets1trial behind it9other products, same developer2rival developers in its markets

About Eticovo / Benepali

Samsung Bioepis's etanercept was the first etanercept biosimilar in Europe, as Benepali through Biogen, in January 2016, and it took much of the European market within a few years. In Canada it is Brenzys, approved in 2016. In the United States it is Eticovo, sold by Organon, approved in 2019 and interchangeable since 2024, but not on sale because of patents.

Status by market

FDA

United States · Eticovo

US Food and Drug AdministrationApproved
Brand
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
Reference product in the Purple Book
Enbrel
Marketing status (Purple Book)
Discontinued
Presentations
25 mg/0.5 mL, 50 mg/mL
Remarks
Not launched in the US.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Benepali

European Medicines Agency and European CommissionApproved
Brand
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
Remarks
First EU etanercept biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Benepali

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Benepali
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
25 mg syringe; 50 mg syringe and pen
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Brenzys

Health CanadaApproved
Brand
Brenzys
Holder or applicant
Samsung Bioepis CO., LTD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Aug 2016
Application or permission
DIN 02455323, 02455331
Presentations
50 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Eticovo / Benepali by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
SB4Samsung BioepisEnbrelPhase 3Comparative efficacyCompletedJun 2013Apr 2014NCT01895309

Other developers in the same markets

Where Eticovo / Benepali holds an approval, these are the other etanercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA1Sandoz (Erelzi)
EMA2Lupin (Nepexto / Fubelv / Lupin etanercept), Sandoz (Erelzi)
MHRA2Lupin (Nepexto / Fubelv / Lupin etanercept), Sandoz (Erelzi)
HC2Lupin (Nepexto / Fubelv / Lupin etanercept), Sandoz (Erelzi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Hadlima / Imraldi, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.

Chronology

Sources

All etanercept biosimilars

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Data current to September 2026.