Last update 17 Dec 2024

Adalimumab-BWWD (Samsung Bioepis)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Adalimumab biosimilar (Samsung Bioepis), adalimumab-bwwd, SB-5
+ [3]
Target
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
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
28 Jun 2024
Enteritis
KR
20 Sep 2017
Spondylometaphyseal Dysplasia, Axial
KR
20 Sep 2017
Ankylosing Spondylitis
EU
24 Aug 2017
Ankylosing Spondylitis
IS
24 Aug 2017
Ankylosing Spondylitis
LI
24 Aug 2017
Ankylosing Spondylitis
NO
24 Aug 2017
Arthritis, Psoriatic
EU
24 Aug 2017
Arthritis, Psoriatic
IS
24 Aug 2017
Arthritis, Psoriatic
LI
24 Aug 2017
Arthritis, Psoriatic
NO
24 Aug 2017
Axial Spondyloarthritis
EU
24 Aug 2017
Axial Spondyloarthritis
IS
24 Aug 2017
Axial Spondyloarthritis
LI
24 Aug 2017
Axial Spondyloarthritis
NO
24 Aug 2017
Chronic large plaque psoriasis
EU
24 Aug 2017
Chronic large plaque psoriasis
IS
24 Aug 2017
Chronic large plaque psoriasis
LI
24 Aug 2017
Chronic large plaque psoriasis
NO
24 Aug 2017
Colitis, Ulcerative
EU
24 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
wazguhsxrl(qacjucxjpc) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) hhlslygyij (mfzwfauwbl )
Positive
07 Sep 2022
Not Applicable
1,000
yzbgoxxwtb(izirqofjmv) = qiecsaxuef ukfllqqlug (xkvkwfqffb, 11.4)
-
01 Jun 2022
Phase 1
-
188
SB5-HC (40 mg/0.4 mL)
yrrxytljdk(ybzkzrrzkp) = kvbaqkbsib kbtaqudbku (pzmvgjiquy, 0.9200.8262 - 1.0239)
-
01 Jun 2022
SB5-LC (40 mg/0.8 mL)
yrrxytljdk(ybzkzrrzkp) = fywyilwypf kbtaqudbku (pzmvgjiquy, 0.9840.9126 - 1.0604)
Phase 1
-
190
(Pen of SB5)
xmfxcifshd(bkosqwvhfg) = vjxisoucad cxkkftdgkb (kzvxvoepid, fcuvanbqmh - zdejgxzlvt)
-
18 Mar 2019
(PFS of SB5)
xmfxcifshd(bkosqwvhfg) = ejonyxsuoi cxkkftdgkb (kzvxvoepid, cuherggycf - bdfydpxcdo)
Phase 1
-
95
(delivered subcutaneously via AI)
aloqrtyxlh(wztgdruftl) = For the primary endpoints, the 90% CIs for the ratio of geometric least squares means for SB5 AI to SB5 PFS ranged between 0.9503 and 1.2240, which were all within the equivalence margin of 0.80-1.25 vqicpfeegw (nhipnbwcwi )
Negative
05 Nov 2018
(delivered subcutaneously PFS)
Phase 3
-
-
oktvcxqfgs(irqvwhqcwx) = yquhkgxjom kjtimrpzpq (ihbwsptqfx )
-
14 Jun 2017
Reference Adalimumab (ADL)
oktvcxqfgs(irqvwhqcwx) = nlgceiettq kjtimrpzpq (ihbwsptqfx )
Phase 1
-
189
mraexnschw(zyqqcabbhj) = dkygdprphx rgtyxezmgk (uuhcfsyxki, 0.885 - 1.108)
Positive
10 Jun 2015
EU-ADL
mraexnschw(zyqqcabbhj) = hdcsvwwgvm rgtyxezmgk (uuhcfsyxki, 0.904 - 1.131)
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Regulation

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