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Last update 20 Sep 2025
Infliximab Biosimilar (Nichi-Iko)
Last update 20 Sep 2025
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms Infliximab Biosimilar (Nichi-Iko Pharmaceutical Co., Ltd.), 英夫利西单抗生物类似药（Nichi-Iko Pharmaceutical Co., Ltd.）, GS 07 + [5] |
Target |
Action inhibitors |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (27 Sep 2017), |
Regulation- |
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Structure/Sequence
Sequence Code 69035L
Source: *****
Sequence Code 69038H
Source: *****
Related
3
Clinical Trials associated with Infliximab Biosimilar (Nichi-Iko)NCT02990806
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
NCT01931189
A Clinical Pharmacokinetics Study of NI-071
NCT01927263
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 Biosimilar (Nichi-Iko)
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100 Translational Medicine associated with Infliximab Biosimilar (Nichi-Iko)
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100 Patents (Medical) associated with Infliximab Biosimilar (Nichi-Iko)
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3
Literatures (Medical) associated with Infliximab Biosimilar (Nichi-Iko)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 Apr 2016Emerging infectious diseasesQ2 · MEDICINE
In Memoriam: Sandy Ford (1950–2015)
Q2 · MEDICINE
ArticleOA
Author: Bloch, Alan B. ; Schultz, Myron G.
100 Deals associated with Infliximab Biosimilar (Nichi-Iko)
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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 | Japan | 20 Jun 2018 | |
| Crohn Disease | Japan | 20 Jun 2018 | |
| Erythrodermic psoriasis | Japan | 20 Jun 2018 | |
| Psoriasis vulgaris | Japan | 20 Jun 2018 | |
| Pustular psoriasis | Japan | 20 Jun 2018 | |
| Rheumatoid Arthritis | Japan | 20 Jun 2018 | |
| Ankylosing Spondylitis | Japan | 27 Sep 2017 | |
| Arthritis, Psoriatic | Japan | 27 Sep 2017 | |
| Behcet's uveitis | Japan | 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) | aemazzbgxa = isshkhmpfm inedphqmbe (hcrqjkjxnr, ioeyfqpbon - xfbtbmbaug) View more | - | 25 Jan 2023 | ||
(Stage 2 and Stage 3: Remicade US to Remicade-US Group) | pohdpdmdgw(cppjsixvdp) = eyhexftnww fyisyxpygo (hbbeltpvfb, 8228379.79) View more | ||||||
Phase 3 | 242 | rlunkrtxsk(jnonfzvogr) = BS demonstrated equivalent efficacy to RP at treatment weeks 14 and 30, sofcmvkxfa (qwuwfdpcbs ) View more | Positive | 01 Nov 2019 | |||
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Biosimilar
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Regulation
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