Last update 11 Jul 2024

Infliximab-dyyb (Celltrion)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Anti-TNF alpha Mab, Anti-TNF alpha monoclonal antibody, Infliximab (dyyb)
+ [10]
Target
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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External Link

KEGGWikiATCDrug Bank
D02598-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Colitis, Ulcerative
LI
10 Sep 2013
Colitis, Ulcerative
IS
10 Sep 2013
Colitis, Ulcerative
IS
10 Sep 2013
Colitis, Ulcerative
EU
10 Sep 2013
Pediatric Crohn's Disease
IS
10 Sep 2013
Pediatric Crohn's Disease
LI
10 Sep 2013
Pediatric Crohn's Disease
NO
10 Sep 2013
Pediatric Crohn's Disease
NO
10 Sep 2013
Pediatric Crohn's Disease
EU
10 Sep 2013
Pediatric Crohn's Disease
LI
10 Sep 2013
Pediatric Crohn's Disease
EU
10 Sep 2013
Pediatric Crohn's Disease
IS
10 Sep 2013
Psoriasis
LI
10 Sep 2013
Psoriasis
NO
10 Sep 2013
Psoriasis
EU
10 Sep 2013
Psoriasis
EU
10 Sep 2013
Psoriasis
IS
10 Sep 2013
Psoriasis
NO
10 Sep 2013
Psoriasis
IS
10 Sep 2013
Psoriasis
LI
10 Sep 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseasePhase 3
CZ
28 Oct 2019
Crohn DiseasePhase 3
ZA
28 Oct 2019
Crohn DiseasePhase 3
RS
28 Oct 2019
Crohn DiseasePhase 3
SK
28 Oct 2019
Crohn DiseasePhase 3
IT
28 Oct 2019
Crohn DiseasePhase 3
TR
28 Oct 2019
Crohn DiseasePhase 3
GR
28 Oct 2019
Crohn DiseasePhase 3
IL
28 Oct 2019
Crohn DiseasePhase 3
MD
28 Oct 2019
Rheumatoid ArthritisDiscovery
KR
01 Mar 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
181
(qwpirhbfpa) = jklytpbxvm gzhcohqmwh (wqhgbcgupa )
-
01 Apr 2023
Combotherapy with Immunosuppressants
(qwpirhbfpa) = vmxmvwystm gzhcohqmwh (wqhgbcgupa )
Phase 3
270
(ytjqyvhllh) = were similar between the groups bhoyrjncff (ozbzxfxsou )
Positive
01 Jun 2022
Not Applicable
118
(rmklxdkkmp) = A total of 22 AEs occurred consistent with the known AE profile for infliximab lyhrpztkkq (hdirpmlviu )
Positive
16 Mar 2022
Phase 1
131
(CT-P13 SC)
qnymmpjpxi(jiogykkihg) = lwoojuqgmi xgipjfdndq (idfxnunbnz )
Positive
01 Jun 2021
(CT-P13 IV)
qnymmpjpxi(jiogykkihg) = ukcssqqsoa xgipjfdndq (idfxnunbnz )
Not Applicable
351
telnedqgmj(bhooyrsvqk) = dpkvmormvz hairrrughc (tgtvlxyknm )
-
01 Jan 2021
Phase 1
181
(Cohort 1: CT-P13 IV 5mg/kg (Part 1))
haxdvgvxnx(qvjzumxxsg) = cyagwfxzvo ibjkanjezr (ymjldwsxbi, yhtgwkkdhr - qbwbunbjap)
-
09 Jun 2020
(Cohort 2: CT-P13 SC 120 mg (Part 1))
haxdvgvxnx(qvjzumxxsg) = mwztvkgmgh ibjkanjezr (ymjldwsxbi, rnrydmybtb - jjyzyekfub)
Phase 3
407
(Cohort 1: CT-P13 IV 3 mg/kg (Part 1))
pyczjpidtb(znsvkgwsbq) = stuassdmxp ljduowucqc (mbtgaoyqrw, qrjxdsjcru - xqlruzzwms)
-
08 Apr 2020
folic acid+MTX+CT-P13
(Cohort 2: CT-P13 SC 90 mg (Part 1))
pyczjpidtb(znsvkgwsbq) = pwdsoswngj ljduowucqc (mbtgaoyqrw, pjlubulnwr - iwxbgdhkmx)
Not Applicable
-
inoqqztwpz(wthymaeumr) = 13 AEs were reported in the CT-P13 group and 17 in the IFX group that led to treatment change or discontinuation rgbgideuer (rehzsyrgwx )
Positive
11 Nov 2019
IFX
Not Applicable
329
CT-P13
oaphuolcur(gcmywwlaez) = Infection-related TEAEs were reported in 10.2% of patients receiving CT-P13 xdpitirkjv (atmroezzsy )
-
12 Jun 2019
Not Applicable
491
nealiqujmg(jjrnbfjxoa) = xwiqjebofh kmdvxfhjpc (gvjwxdzblk )
Positive
12 Jun 2019
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