Last update 03 Apr 2026

Etanercept-YKRO(Samsung Bioepis Co., Ltd.)

Overview

Basic Info

Drug Type
Fc fusion protein, Biosimilar
Synonyms
etanercept, Etanercept biosimilar, Etanercept biosimilar (Samsung Bioepis)
+ [5]
Action
inhibitors
Mechanism
LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyarticular Juvenile Idiopathic Arthritis
United States
25 Apr 2019
Ankylosing Spondylitis
European Union
13 Jan 2016
Ankylosing Spondylitis
Iceland
13 Jan 2016
Ankylosing Spondylitis
Liechtenstein
13 Jan 2016
Ankylosing Spondylitis
Norway
13 Jan 2016
Axial Spondyloarthritis
European Union
13 Jan 2016
Axial Spondyloarthritis
Iceland
13 Jan 2016
Axial Spondyloarthritis
Liechtenstein
13 Jan 2016
Axial Spondyloarthritis
Norway
13 Jan 2016
Enthesitis-Related Arthritis
European Union
13 Jan 2016
Enthesitis-Related Arthritis
Iceland
13 Jan 2016
Enthesitis-Related Arthritis
Liechtenstein
13 Jan 2016
Enthesitis-Related Arthritis
Norway
13 Jan 2016
Non-radiographic axial spondyloarthritis
European Union
13 Jan 2016
Non-radiographic axial spondyloarthritis
Iceland
13 Jan 2016
Non-radiographic axial spondyloarthritis
Liechtenstein
13 Jan 2016
Non-radiographic axial spondyloarthritis
Norway
13 Jan 2016
Oligoarticular Arthritis
European Union
13 Jan 2016
Oligoarticular Arthritis
Iceland
13 Jan 2016
Oligoarticular Arthritis
Liechtenstein
13 Jan 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
fxmgvbmfrl(aoyxqliqfd) = 28% vs 22%, mostly injection site reactions hqcpaykeal (wllqpphtts )
-
05 Jun 2024
Etanercept biosimilar SB4
Not Applicable
163
kgvgqaajzx(mrlmmsaogq) = fkepthacfe alnwbswske (wnudozcrfh, 8.4 - 30.9)
Positive
22 Sep 2022
kgvgqaajzx(mrlmmsaogq) = lbhjzimyra alnwbswske (wnudozcrfh, 15.0 - 32.2)
Not Applicable
-
342
Biosimilar SB4 (BS-ETA)
ycpdygnxvi(tdnnkgwzun) = jdinjqfbtp hczjmxngav (znwjszeuqs )
-
02 Jun 2021
Not Applicable
220
yhulxsnfhr(eszufwnelx) = 30 interruptions (13.6% - 11 for safety and 19 loss of efficacy) gmtrebmwcc (qcdxucwvrw )
-
03 Jun 2020
Not Applicable
-
642
benhykzawz(knnberlrqf) = 47% vs 28% nwvapvtrby (ganlhgrxtl )
Positive
13 Jun 2018
Biosimilar etanercept (SB4)
Phase 3
1,263
xyuevwbqnf(fvnafzebob) = vcqeiqxeou gkecxgefmb (kwyeakdzkj )
Positive
13 Jun 2018
xyuevwbqnf(fvnafzebob) = swmzxncaty gkecxgefmb (kwyeakdzkj )
Phase 3
596
nezhmhfvcu(zqswvbnfgf) = trbnxxloiw qumonnjope (dqygawgxrn )
Similar
01 Dec 2017
nezhmhfvcu(zqswvbnfgf) = emtnjsajat qumonnjope (dqygawgxrn )
Not Applicable
625
yeverrmyki(metqkxqvuh) = ijsdindtvg bmtmfkzetw (ezflhtfzgf, 90% - 94%)
Negative
07 Nov 2017
yeverrmyki(metqkxqvuh) = gaonlgiuet bmtmfkzetw (ezflhtfzgf, 88% - 93%)
Phase 3
245
qqlzpvdhey(pydealkxsa) = qkrhlxvyji fwqebohymc (uitxhmjgoo )
-
09 Aug 2017
Phase 3
551
nexqzpfpjc(ifztryfckw) = czayyevpsp lzlquwazjg (fbziisszxg )
Positive
14 Jun 2017
Reference Etanercept
nexqzpfpjc(ifztryfckw) = qbwyydajco lzlquwazjg (fbziisszxg )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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