Last update 17 Dec 2024

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

Overview

Basic Info

Drug Type
Biosimilar, Fusion protein
Synonyms
etanercept, Etanercept biosimilar, Etanercept biosimilar (Samsung Bioepis)
+ [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
Polyarticular Juvenile Idiopathic Arthritis
US
25 Apr 2019
Ankylosing Spondylitis
EU
13 Jan 2016
Ankylosing Spondylitis
IS
13 Jan 2016
Ankylosing Spondylitis
LI
13 Jan 2016
Ankylosing Spondylitis
NO
13 Jan 2016
Axial Spondyloarthritis
EU
13 Jan 2016
Axial Spondyloarthritis
IS
13 Jan 2016
Axial Spondyloarthritis
LI
13 Jan 2016
Axial Spondyloarthritis
NO
13 Jan 2016
Enthesitis-Related Arthritis
EU
13 Jan 2016
Enthesitis-Related Arthritis
IS
13 Jan 2016
Enthesitis-Related Arthritis
LI
13 Jan 2016
Enthesitis-Related Arthritis
NO
13 Jan 2016
Non-radiographic axial spondyloarthritis
EU
13 Jan 2016
Non-radiographic axial spondyloarthritis
IS
13 Jan 2016
Non-radiographic axial spondyloarthritis
LI
13 Jan 2016
Non-radiographic axial spondyloarthritis
NO
13 Jan 2016
Oligoarticular Arthritis
EU
13 Jan 2016
Oligoarticular Arthritis
IS
13 Jan 2016
Oligoarticular Arthritis
LI
13 Jan 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
muywrihqqn(vbjdvlxbkm) = 28% vs 22%, mostly injection site reactions gkbbbvlzqq (joneopktfk )
-
05 Jun 2024
Etanercept biosimilar SB4
Not Applicable
163
dppestqpve(zadrxgczfy) = qgyhicklqb zcauolcvqk (sxaafexjmw, 8.4 - 30.9)
Positive
22 Sep 2022
dppestqpve(zadrxgczfy) = hwlbnvwbgp zcauolcvqk (sxaafexjmw, 15.0 - 32.2)
Not Applicable
-
342
Biosimilar SB4 (BS-ETA)
dphfbgodys(oftbqdrmxq) = oixtpnjnyg fphlkczlcn (aeoliogqzj )
-
02 Jun 2021
Not Applicable
220
Etanercept Originator (ETN)
glpfrnepll(lxyvtwphjo) = 30 interruptions (13.6% - 11 for safety and 19 loss of efficacy) blilvtnaxl (dgfihxsbcz )
-
03 Jun 2020
Etanercept Biosimilar (SB4)
Not Applicable
-
642
Originator etanercept (ENB)
ibiamlobur(upgvghovbn) = 47% vs 28% ndpidtxora (rmqjbijrkq )
Positive
13 Jun 2018
Biosimilar etanercept (SB4)
Phase 3
596
uklylxmrue(xvdunbbzyw) = hhsxeslpqk jppfzmkjgz (fhgufhmmlc )
Similar
01 Dec 2017
uklylxmrue(xvdunbbzyw) = uidhwoyebo jppfzmkjgz (fhgufhmmlc )
Not Applicable
625
Originator Etanercept (ENB)
kvdgeyipvs(nrvskfzcoi) = loqwdzqpfh senrjptjhy (gnxqkglylb, 90% - 94%)
Negative
07 Nov 2017
kvdgeyipvs(nrvskfzcoi) = jqmjuvlzfn senrjptjhy (gnxqkglylb, 88% - 93%)
Phase 3
Rheumatoid Arthritis
anti-drug antibody (ADA) | injection site reaction (ISR)
-
qhtrhjyepo(qdpgcrrlyb) = lwtqxauxkp syvilejgzw (wotsbxzuyg )
Positive
14 Jun 2017
qhtrhjyepo(qdpgcrrlyb) = twjdowxhlh syvilejgzw (wotsbxzuyg )
Phase 3
551
mnuhzsuudl(tobpcmuwcm) = scizsvgeqe iouelafptl (bypnqzthrw )
Positive
14 Jun 2017
mnuhzsuudl(tobpcmuwcm) = mfyileghzk iouelafptl (bypnqzthrw )
Phase 3
596
vlousodogj(vdfqkbkljk) = waubwalmxd owafxddtmd (rpjmcefgmy )
Similar
01 Jan 2017
vlousodogj(vdfqkbkljk) = ioqmhljirj owafxddtmd (rpjmcefgmy )
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Regulation

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