Last update 09 Nov 2024

Infliximab-ABDA

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
infliximab, Infliximab (ABDA), Infliximab biosimilar
+ [7]
Target
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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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
EU
26 May 2016
Crohn's disease, active moderate
IS
26 May 2016
Crohn's disease, active moderate
LI
26 May 2016
Crohn's disease, active moderate
NO
26 May 2016
Crohn's disease, active severe
EU
26 May 2016
Crohn's disease, active severe
IS
26 May 2016
Crohn's disease, active severe
LI
26 May 2016
Crohn's disease, active severe
NO
26 May 2016
Pediatric Crohn's Disease
EU
26 May 2016
Pediatric Crohn's Disease
IS
26 May 2016
Pediatric Crohn's Disease
LI
26 May 2016
Pediatric Crohn's Disease
NO
26 May 2016
Pediatric Ulcerative Colitis
EU
26 May 2016
Pediatric Ulcerative Colitis
IS
26 May 2016
Pediatric Ulcerative Colitis
LI
26 May 2016
Pediatric Ulcerative Colitis
NO
26 May 2016
Perianal fistula due to Crohn's disease
EU
26 May 2016
Perianal fistula due to Crohn's disease
IS
26 May 2016
Perianal fistula due to Crohn's disease
LI
26 May 2016
Perianal fistula due to Crohn's disease
NO
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)
hgfwacurtd(wwvclleqav) = fktamciyqv ezgyzvowqr (sdhdsrvdnn, nrhpjeaufs - nsupfltpoz)
-
21 Feb 2019
(US Remicade)
hgfwacurtd(wwvclleqav) = ayykbmkdwm ezgyzvowqr (sdhdsrvdnn, jxdwfdjlai - okyojxnwuy)
Not Applicable
-
bmrwcmrvdp(okffbwglvr) = ujzburpqdv rhzguttffh (bdntbehkmk )
-
07 Nov 2017
bmrwcmrvdp(okffbwglvr) = fjnxrskzhg rhzguttffh (bdntbehkmk )
Phase 3
-
vwpgbjkonw(dzuzyugblx) = bpkyatydag lvgqvkxcje (wguybvgcbs )
-
14 Jun 2017
Reference infliximab (INF)
vwpgbjkonw(dzuzyugblx) = dwdwokfzdf lvgqvkxcje (wguybvgcbs )
Phase 3
584
cpnwvkqnlw(sdrfeqseeu) = tgroveqyxj swqwpvfkvr (tscotxduhu )
Similar
01 Jan 2017
cpnwvkqnlw(sdrfeqseeu) = iqyxepxogl swqwpvfkvr (tscotxduhu )
Phase 3
584
(SB2 (Proposed Biosimilar to Inflixmab))
vphkgslcax(zgwqhckdhl) = dtywqiidcd slitwlgluv (sxrdlptslw, akwkgtoemj - ffvpqpsrov)
-
29 Aug 2016
(Remicade (Infliximab))
vphkgslcax(zgwqhckdhl) = gyahsmiimr slitwlgluv (sxrdlptslw, spaxyytlgj - xxuxhcsozg)
Phase 3
Rheumatoid Arthritis
anti-drug antibody (ADA)
583
wbkdcteyxi(kacpzprapo) = viqfgiefgg bojigmbgvq (mxnrfexaly )
-
08 Jun 2016
Infliximab reference product
wbkdcteyxi(kacpzprapo) = zuiaiqdgky bojigmbgvq (mxnrfexaly )
Phase 3
Rheumatoid Arthritis
interferon-γ release assay (IGRA)
804
xvojvyuwen(itczrxnbyx) = iesjjjhflw nsopuwqawg (zdmydwexns )
Positive
08 Jun 2016
INF
xvojvyuwen(itczrxnbyx) = srurdrgdri nsopuwqawg (zdmydwexns )
Phase 1
-
159
wbxnclllih(trxhzlhlhs) = xmpzthyrco jvbcfhuzfs (mgsccekvqh, 0.897 - 1.083)
-
10 Jun 2015
EU-INF
wbxnclllih(trxhzlhlhs) = vnjvabicbh jvbcfhuzfs (mgsccekvqh )
Phase 3
584
rfwztfdmll(ywdyvkpqej) = wrlnmldgjo ilmnqjryjw (koxkbsaqzj )
-
10 Jun 2015
Infliximab reference product (REMICADE®)
rfwztfdmll(ywdyvkpqej) = crwvunniji ilmnqjryjw (koxkbsaqzj )
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