Last update 11 Dec 2024
Infliximab(Nichi-Iko Pharmaceutical)
Last update 11 Dec 2024
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms Infliximab biosimilar (Nichiiko Pharmaceutical/Aprogen), GS 071, GS-071 + [1] |
Target |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date JP (27 Sep 2017), |
Regulation- |
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Gene Sequence
Sequence Code 69035L
Source: *****
Sequence Code 69038H
Source: *****
Related
3
Clinical Trials associated with Infliximab(Nichi-Iko Pharmaceutical)A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis
A Clinical Pharmacokinetics Study of NI-071
A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
100 Clinical Results associated with Infliximab(Nichi-Iko Pharmaceutical)
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100 Translational Medicine associated with Infliximab(Nichi-Iko Pharmaceutical)
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100 Patents (Medical) associated with Infliximab(Nichi-Iko Pharmaceutical)
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6
Literatures (Medical) associated with Infliximab(Nichi-Iko Pharmaceutical)01 Mar 2023Zeitschrift fur Rheumatologie
Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate
Article
Author: Lee, Young Ho ; Song, Gwan Gyu
02 Nov 2019Modern rheumatologyQ4 · MEDICINE
A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate
Q4 · MEDICINE
Article
Author: Matsuno, Hiroaki ; Matsubara, Tsukasa
01 May 2010Praxis
Article
Author: Bérthet ; Bolt ; Hofer ; Schalm ; Cannizzaro ; Sauvain ; Kaiser ; Saurenmann ; Bolz
100 Deals associated with Infliximab(Nichi-Iko Pharmaceutical)
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R&D Status
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Colitis, Ulcerative | JP | 20 Jun 2018 | |
| Crohn Disease | JP | 20 Jun 2018 | |
| Erythrodermic psoriasis | JP | 20 Jun 2018 | |
| Psoriasis vulgaris | JP | 20 Jun 2018 | |
| Pustular psoriasis | JP | 20 Jun 2018 | |
| Rheumatoid Arthritis | JP | 20 Jun 2018 | |
| Ankylosing Spondylitis | JP | 27 Sep 2017 | |
| Arthritis, Psoriatic | JP | 27 Sep 2017 | |
| Behcet's uveitis | JP | 27 Sep 2017 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 3 | 683 | (Stage 1: Remicade-US Group) | qlfaulmcov(zwzivbjohf) = qoenohyqfg smgtpptaex (byworxkozs, icmwhybcna - fkjmxpwbzu) View more | - | 25 Jan 2023 | ||
(Stage 2 and Stage 3: Remicade US to Remicade-US Group) | doefktvfks(qlbewjptww) = ubsjfnvcbn gkgarkgtii (kipmrnepsk, xuunpzsoyq - xvabqolzhg) View more | ||||||
Phase 3 | 242 | mniyficwsc(nijzmlqnfn) = BS demonstrated equivalent efficacy to RP at treatment weeks 14 and 30, eoihkekkzs (iwqshgmadk ) View more | Positive | 01 Nov 2019 | |||
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