Last update 31 May 2025

Infliximab-dyyb (Celltrion)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Anti-TNF alpha Mab, Anti-TNF alpha monoclonal antibody, Infliximab Biosimilar (Celltrion, Inc.)
+ [13]
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
D02598-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Behcet's uveitis
Japan
01 Apr 2020
Erythrodermic psoriasis
Japan
22 Jul 2015
Erythrodermic psoriasis
Japan
22 Jul 2015
Psoriasis vulgaris
Japan
22 Jul 2015
Psoriasis vulgaris
Japan
22 Jul 2015
Pustular psoriasis
Japan
22 Jul 2015
Pustular psoriasis
Japan
22 Jul 2015
Ankylosing Spondylitis
European Union
10 Sep 2013
Ankylosing Spondylitis
European Union
10 Sep 2013
Ankylosing Spondylitis
Iceland
10 Sep 2013
Ankylosing Spondylitis
Iceland
10 Sep 2013
Ankylosing Spondylitis
Liechtenstein
10 Sep 2013
Ankylosing Spondylitis
Liechtenstein
10 Sep 2013
Ankylosing Spondylitis
Norway
10 Sep 2013
Ankylosing Spondylitis
Norway
10 Sep 2013
Arthritis, Psoriatic
European Union
10 Sep 2013
Arthritis, Psoriatic
European Union
10 Sep 2013
Arthritis, Psoriatic
Iceland
10 Sep 2013
Arthritis, Psoriatic
Iceland
10 Sep 2013
Arthritis, Psoriatic
Liechtenstein
10 Sep 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autoimmune DiseasesPreclinical
United Kingdom
20 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
CT-P13 SC 120 mg
jlltfxgymj(mwrqsekbhy) = hdixjyirqf ezbtvbjgpj (nsncyolxff )
Positive
23 May 2024
Placebo
jlltfxgymj(mwrqsekbhy) = lbbnswdkmt ezbtvbjgpj (nsncyolxff )
NEWS
ManualManual
Phase 3
-
CT-P13 SC
(Crohn's disease)
lapvvwdaeo(miuruwjpdx) = The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks ldaoeyfrda (kowdihzrud )
Positive
16 Oct 2023
CT-P13 SC
(ulcerative colitis)
Phase 1
Inflammatory Bowel Diseases
Maintenance
anti-drug antibody | neutralising antibody
131
ovpvccrpbg(jrbqfgxmcn) = xfylajrkin zkmnniwhoz (espuvpobyv )
Positive
09 May 2023
ovpvccrpbg(jrbqfgxmcn) = frtiuwfgth zkmnniwhoz (espuvpobyv )
Phase 1
Inflammatory Bowel Diseases
Maintenance
anti-drug antibody | neutralising antibody
131
xnnkhlcdak(mijbmpdddc) = fdwohgbsgg pqjjrljurs (jydfiqlbic )
Positive
09 May 2023
xnnkhlcdak(mijbmpdddc) = ijfuemvcns pqjjrljurs (jydfiqlbic )
Not Applicable
-
-
CT-P13 SC 120 mg
nxqapcieys(kfbawdwagh) = mikcdiuljy qznyhagqqv (fstudjxqhm )
-
09 May 2023
Placebo SC
nxqapcieys(kfbawdwagh) = eiqdqmqune qznyhagqqv (fstudjxqhm )
Not Applicable
-
kivvwuuxtx(qleqylerjr) = llgemjjzia czeiyplmlc (tuzjypdemq, 19 - 142)
-
09 May 2023
kivvwuuxtx(qleqylerjr) = brlixiifhx czeiyplmlc (tuzjypdemq, 14 - 129)
Phase 1
Inflammatory Bowel Diseases
Maintenance
anti-drug antibody | neutralising antibody
131
jgfkjfxtzn(vrwdynkjpv) = rtfxgloyqa ngmxspyfdm (yridswqcgi )
Positive
09 May 2023
jgfkjfxtzn(vrwdynkjpv) = hyxgcgycgv ngmxspyfdm (yridswqcgi )
Phase 1
181
SC Infliximab Monotherapy
neizsikszs(dbavfmwbwr) = qfpbtuyder ahxegzubgp (hicofcqscp )
-
01 Apr 2023
Combotherapy with Immunosuppressants
neizsikszs(dbavfmwbwr) = qycnzphojl ahxegzubgp (hicofcqscp )
Phase 3
270
astbogrzhb(xlyfdgzhme) = were similar between the groups zemnhrbspv (vogpafsxgp )
Positive
01 Jun 2022
Not Applicable
-
Infliximab
lihwskondz(wqkxlksgzg) = no significant differences were observed between placebo, comparators or any biologic lpvxozbztw (rddqaqgurx )
-
22 May 2022
Adalimumab
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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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