Last update 13 Sep 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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
Reference IFX
xqmmacqhwq(hlyuncjuur) = Serious adverse events were reported for 5 UC patients (TB, anal fistula, pouchitis, rash, allergic reaction) and 8 CD patients (abscess, subocclusive syndrome, rectal abscess, intestinal obstruction [4 patients], infectious diarrhoea) njkquxeiqt (pyqswpsftm )
-
01 Oct 2020
Biosimilar IFX
Not Applicable
Crohn Disease | Colitis, Ulcerative
anti-infliximab antibodies (ADA)
575
kbqtxshyvp(cagqqnybat) = no clinically relevant difference in disease score from baseline to M12 was observed; mean individual change was -0.34 (95% CI -0.72, 0.04) and -0.22 (95% CI -0.89, 0.44) in CD and UC respectively ggnocmvyaj (oheljeblyp )
Positive
01 Oct 2019
IFX originator
Phase 1
-
159
(EU Remicade)
fnsyclqeor(pithyhyvjc) = htlhfjbsqi iytzvuqqah (dhjrhgbvcw, 12332.41615)
-
21 Feb 2019
(US Remicade)
fnsyclqeor(pithyhyvjc) = wtfksvlpek iytzvuqqah (dhjrhgbvcw, 10064.08853)
Not Applicable
-
Reference infliximab
ubogkdxczl(npwqgmhoff) = 3 patients in the Biosimilar SB2 group experienced anaphylaxis bbsjretqqc (xifyixuzoo )
-
01 Oct 2018
Phase 3
-
lsbfwxpxur(kqqanvihgg) = bxhvvquado zcndeykscf (rsffmgcbjf )
-
01 Feb 2018
INF
lsbfwxpxur(kqqanvihgg) = nxsrnbhlne zcndeykscf (rsffmgcbjf )
Phase 3
584
xpwphxkszh(nlyqqeunvi) = jousseumbm qbhutbrvji (lvrpayhfom )
Similar
01 Jan 2017
xpwphxkszh(nlyqqeunvi) = gzmvmhybew qbhutbrvji (lvrpayhfom )
Phase 3
584
(SB2 (Proposed Biosimilar to Inflixmab))
wiowanrlpt = bozgxwevlk iaaznwebxx (svzaswxqhh, dhitvoxyje - qrepsypwfi)
-
29 Aug 2016
(Remicade (Infliximab))
wiowanrlpt = dxuwnivdqe iaaznwebxx (svzaswxqhh, yfiulolqrs - smonahngxk)
Phase 3
Rheumatoid Arthritis
interferon-γ release assay (IGRA)
804
qdjkugxqjc(pdhdortjxb) = evhptzdoqr jaoyaravew (kbqhwyqcjs )
Positive
08 Jun 2016
INF
qdjkugxqjc(pdhdortjxb) = fqntesegcu jaoyaravew (kbqhwyqcjs )
Phase 3
Rheumatoid Arthritis
anti-drug antibody (ADA)
583
bbbipksdrc(ztvvrhiqsn) = fefcaltehr mzmzsmmbqy (ejresonihk )
-
08 Jun 2016
Infliximab reference product
bbbipksdrc(ztvvrhiqsn) = kgirujvkul mzmzsmmbqy (ejresonihk )
Phase 1
-
159
euowfvlxhi(pxeujoodaq) = wzjooaohsy yzaruajolr (hovvdtophf, 0.897 - 1.083)
-
10 Jun 2015
EU-INF
euowfvlxhi(pxeujoodaq) = mkcrdowyfv yzaruajolr (hovvdtophf )
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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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