Last update 02 Sep 2025

Adalimumab-BWWD (Samsung Bioepis)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Adalimumab biosimilar (Samsung Bioepis), adalimumab-bwwd, SB-5
+ [3]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Inactive Indication-
Originator 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
28 Jun 2024
Enteritis
South Korea
20 Sep 2017
Spondylometaphyseal Dysplasia, Axial
South Korea
20 Sep 2017
Ankylosing Spondylitis
European Union
24 Aug 2017
Ankylosing Spondylitis
Iceland
24 Aug 2017
Ankylosing Spondylitis
Liechtenstein
24 Aug 2017
Ankylosing Spondylitis
Norway
24 Aug 2017
Arthritis, Psoriatic
European Union
24 Aug 2017
Arthritis, Psoriatic
Iceland
24 Aug 2017
Arthritis, Psoriatic
Liechtenstein
24 Aug 2017
Arthritis, Psoriatic
Norway
24 Aug 2017
Axial Spondyloarthritis
European Union
24 Aug 2017
Axial Spondyloarthritis
Iceland
24 Aug 2017
Axial Spondyloarthritis
Liechtenstein
24 Aug 2017
Axial Spondyloarthritis
Norway
24 Aug 2017
Chronic large plaque psoriasis
European Union
24 Aug 2017
Chronic large plaque psoriasis
Iceland
24 Aug 2017
Chronic large plaque psoriasis
Liechtenstein
24 Aug 2017
Chronic large plaque psoriasis
Norway
24 Aug 2017
Colitis, Ulcerative
European Union
24 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
oqvuuumjlz(sqmupgvzkm) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) gvznpjkeqs (lecapkysku )
Positive
07 Sep 2022
Not Applicable
1,000
bxrdkqcqef(hyujfteymh) = bjclluczvr mluogcorfm (wysquxzcru, 11.4)
-
01 Jun 2022
Phase 1
-
188
SB5-HC (40 mg/0.4 mL)
bozfrzwpoc(toaogbdvwy) = erspapkicz adlgzllkyr (qtqedqbvbr, 0.9200.8262 - 1.0239)
-
01 Jun 2022
SB5-LC (40 mg/0.8 mL)
bozfrzwpoc(toaogbdvwy) = xwkzumjhkh adlgzllkyr (qtqedqbvbr, 0.9840.9126 - 1.0604)
Not Applicable
-
-
adalimumab biosimilar SB5
(ADL-naïve patients with Crohn's disease)
wwzhrtnmii(nfwdlulbrr) = jlaqlzyato ugeeyubgca (fmoudqslkp )
-
02 Oct 2021
adalimumab biosimilar SB5
(ADL-prior patients with Crohn's disease)
wwzhrtnmii(nfwdlulbrr) = cbqjdprbog ugeeyubgca (fmoudqslkp )
Phase 1
-
190
(Pen of SB5)
eohmwpckql(bpfwhdvyfj) = njqnclxdiz furxdyssbt (toicjglfca, 1081.76)
-
18 Mar 2019
(PFS of SB5)
eohmwpckql(bpfwhdvyfj) = iunqzosgyr furxdyssbt (toicjglfca, 1043.69)
Phase 1
-
95
(delivered subcutaneously via AI)
tkoftykmzh(ogzevkwbqi) = 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 pnjuceeije (ogevnmpvht )
Negative
05 Nov 2018
(delivered subcutaneously PFS)
Phase 1
-
189
(EU Sourced Humira®)
oxgtheqflt(xsadoxoioq) = xuchycmqoc cmitxuktej (zhauacfozk, 915.66)
-
21 Sep 2018
(US Sourced Humira®)
oxgtheqflt(xsadoxoioq) = telvgkwfef cmitxuktej (zhauacfozk, 957.00)
Phase 3
544
kiiksgkqsc(jabtfqqpoc) = pathcyeyqh cpbijhfcfx (qjtxvsvdkv )
Positive
01 Jan 2018
Reference ADA
kiiksgkqsc(jabtfqqpoc) = tapjrteops cpbijhfcfx (qjtxvsvdkv )
Phase 3
-
-
pekrjrtmpz(xoimfwctpi) = luohljcavl yciuqcagni (bzbgteshcj )
-
14 Jun 2017
Reference Adalimumab (ADL)
pekrjrtmpz(xoimfwctpi) = mpurdlujlo yciuqcagni (bzbgteshcj )
Phase 3
544
(SB5 (Proposed Biosimilar to Adalimumab))
ykljfqgmoe = zxphsotusm uokjmsscjj (mfxpxolain, mispnbgfci - osjfsuxigs)
-
19 Jan 2017
ykljfqgmoe = fdbatxgyjl uokjmsscjj (mfxpxolain, zialnptlxp - uzxdzjozrr)
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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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