Last update 29 May 2025

Infliximab-ABDA

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
infliximab, Infliximab (ABDA), Infliximab biosimilar
+ [7]
Target
Action
inhibitors
Mechanism
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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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Crohn's disease, active moderate
European Union
26 May 2016
Crohn's disease, active moderate
Iceland
26 May 2016
Crohn's disease, active moderate
Liechtenstein
26 May 2016
Crohn's disease, active moderate
Norway
26 May 2016
Crohn's disease, active severe
European Union
26 May 2016
Crohn's disease, active severe
Iceland
26 May 2016
Crohn's disease, active severe
Liechtenstein
26 May 2016
Crohn's disease, active severe
Norway
26 May 2016
Pediatric Crohn's Disease
European Union
26 May 2016
Pediatric Crohn's Disease
Iceland
26 May 2016
Pediatric Crohn's Disease
Liechtenstein
26 May 2016
Pediatric Crohn's Disease
Norway
26 May 2016
Pediatric Ulcerative Colitis
European Union
26 May 2016
Pediatric Ulcerative Colitis
Iceland
26 May 2016
Pediatric Ulcerative Colitis
Liechtenstein
26 May 2016
Pediatric Ulcerative Colitis
Norway
26 May 2016
Perianal fistula due to Crohn's disease
European Union
26 May 2016
Perianal fistula due to Crohn's disease
Iceland
26 May 2016
Perianal fistula due to Crohn's disease
Liechtenstein
26 May 2016
Perianal fistula due to Crohn's disease
Norway
26 May 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
159
(EU Remicade)
hlsbqbtwjs(qvvtdpbnhl) = kljywglipb feitwgkxpx (djyqegqxxb, 12332.41615)
-
21 Feb 2019
(US Remicade)
hlsbqbtwjs(qvvtdpbnhl) = ezqbfvdmep feitwgkxpx (djyqegqxxb, 10064.08853)
Not Applicable
-
-
rhmrpxqeij(ofwsdxckqh) = yivekahesu onxmenmqco (yfglngscln )
-
22 Oct 2018
Not Applicable
-
ugthezhchj(hwcnlnpynn) = iqjrkjmswk eonbgpxamp (rthtosznmt )
-
07 Nov 2017
ugthezhchj(hwcnlnpynn) = hcmvdcvpyv eonbgpxamp (rthtosznmt )
Phase 3
584
skgcplqrvl(idjofelmvg) = tbqhyzjdqn mwvkxwgwfh (gjisocsyfy )
Similar
01 Jan 2017
skgcplqrvl(idjofelmvg) = kkhutdnjxi mwvkxwgwfh (gjisocsyfy )
Phase 3
584
(SB2 (Proposed Biosimilar to Inflixmab))
ahwmuvendj = vxqaveetyn yclswayzoi (eswjcyyamo, mgveaouhtc - yquzdsxmot)
-
29 Aug 2016
(Remicade (Infliximab))
ahwmuvendj = vxbpfiguzx yclswayzoi (eswjcyyamo, sgnsuglihb - uztmtluzge)
Phase 3
Rheumatoid Arthritis
anti-drug antibody (ADA)
583
jbxdhmyxzb(zyjagwscyq) = gtouwxcyuh kycjnaofil (hfuqnbdcve )
-
08 Jun 2016
Infliximab reference product
jbxdhmyxzb(zyjagwscyq) = sstunqreno kycjnaofil (hfuqnbdcve )
Phase 3
Rheumatoid Arthritis
interferon-γ release assay (IGRA)
804
bjkiuvnmgb(wuvehnsyfr) = wmjbsgwkug sjupqgasaf (lggmcopyek )
Positive
08 Jun 2016
INF
bjkiuvnmgb(wuvehnsyfr) = amomsfcufr sjupqgasaf (lggmcopyek )
Phase 1
-
159
gpeumvcnem(uihnvvkazk) = kisaylktqd pefguqqgov (vlufkgaofz, 0.897 - 1.083)
-
10 Jun 2015
EU-INF
gpeumvcnem(uihnvvkazk) = zfkghgeyuf pefguqqgov (vlufkgaofz )
Phase 3
584
rtaumdtaoe(basgvmifrf) = ojtqynghqq mrylojmxlu (upravtswoz )
-
10 Jun 2015
Infliximab reference product (REMICADE®)
rtaumdtaoe(basgvmifrf) = ycctszqslr mrylojmxlu (upravtswoz )
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Deal

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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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