Last update 16 May 2024

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

Overview

Basic Info

Drug Type
Biosimilar, Fusion protein
Synonyms
Etanercept biosimilar, Etanercept biosimilar (Samsung Bioepis), etanercept
+ [5]
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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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Enthesitis-Related Arthritis
EU
13 Jan 2016
Enthesitis-Related Arthritis
NO
13 Jan 2016
Enthesitis-Related Arthritis
IS
13 Jan 2016
Enthesitis-Related Arthritis
LI
13 Jan 2016
Oligoarticular Arthritis
NO
13 Jan 2016
Oligoarticular Arthritis
LI
13 Jan 2016
Oligoarticular Arthritis
EU
13 Jan 2016
Oligoarticular Arthritis
IS
13 Jan 2016
Plaque psoriasis
EU
13 Jan 2016
Plaque psoriasis
IS
13 Jan 2016
Plaque psoriasis
NO
13 Jan 2016
Plaque psoriasis
LI
13 Jan 2016
Polyarthritis
IS
13 Jan 2016
Polyarthritis
LI
13 Jan 2016
Polyarthritis
NO
13 Jan 2016
Arthritis, Psoriatic
KR
07 Sep 2015
Juvenile Arthritis
KR
07 Sep 2015
Psoriasis
KR
07 Sep 2015
Rheumatoid Arthritis
KR
07 Sep 2015
Spondylometaphyseal Dysplasia, Axial
KR
07 Sep 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Maintenance
8,149
(fbzwtwnvcy) = vrylbfjnkm nzzdpqqkzn (ynppczzvjs )
-
12 Jun 2019
(egdzbfcdho) = gvfvbawnyu lzzqwqlrgu (ywlfowpnns, 65 - 79)
Phase 3
596
(tuzzffcfbx) = nfabirwpnx xexpmsecpl (uvrhmpotdg )
Similar
01 Dec 2017
(tuzzffcfbx) = uzjqokhmdp xexpmsecpl (uvrhmpotdg )
Not Applicable
-
9,274
(clbgivnnfc): HR = 0.87 (95% CI, 0.79 - 0.95)
Positive
02 Jun 2021
Phase 3
1,263
rvlpdekjxf(dczpmwpyrj) = bfknupclvt jhcgfyppvl (zqxyudidbf )
Positive
13 Jun 2018
rvlpdekjxf(dczpmwpyrj) = xnlgwfrazf jhcgfyppvl (zqxyudidbf )
Not Applicable
-
642
hiejchyvht(hhstzmeyil): adjusted hazard ratio = 1.57 (95% CI, 1.05 - 2.36)
-
01 Sep 2018
Not Applicable
477
Etanercept originator
(atdflawgth) = gyaljfvzhn fzimbmbzfp (lgeoajbyjw )
-
03 Jun 2020
(atdflawgth) = eqtzrvsfan fzimbmbzfp (lgeoajbyjw )
Not Applicable
Rheumatic Diseases
anti-drug antibodies (ADAbs) | neutralising antibodies (nAbs)
-
ctkkewcebs(qzzuqdmshe) = uhtmvluapn htwvkhmhgn (xfkkxsawjn )
-
13 Jun 2018
ctkkewcebs(qzzuqdmshe) = sytnagbiph htwvkhmhgn (xfkkxsawjn )
Not Applicable
163
(pscfiybcec) = ktrylivkyf gpnixureps (qjaiqodfzz, 8.4 ~ 30.9)
Positive
22 Sep 2022
(pscfiybcec) = fkapeopgas gpnixureps (qjaiqodfzz, 15.0 ~ 32.2)
Phase 3
596
(mwmyeodpet) = cjrqndogoz lhrryltfib (nzbjnjrunh )
Similar
01 Jan 2017
(mwmyeodpet) = waeiatzztq lhrryltfib (nzbjnjrunh )
Not Applicable
-
56
(xzlwyoryos) = 89% (n=8) was due to loss of efficacy, whilst 11% (n=1) reported side effects ecnmtzibrp (ylqblotmzh )
-
13 Jun 2018
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Approval

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Regulation

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