Delving into the Latest Updates on Infliximab(Nichi-Iko Pharmaceutical) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infliximab biosimilar (Nichiiko Pharmaceutical/Aprogen)

+ [1]

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [6]

Active Indication

Colitis, UlcerativeCrohn DiseaseErythrodermic psoriasis+ [6]

Inactive Indication-

Originator Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Active Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (27 Sep 2017),

Ankylosing SpondylitisArthritis, PsoriaticBehcet's uveitis

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 69035L

Source: *****

Sequence Code 69038H

Source: *****

OBJECTIVETo assess the relative efficacy and safety of infliximab and its biosimilars in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).METHODSWe performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs), comparing the efficacy and safety of infliximab biosimilars versus the originator product in patients with active RA despite receiving MTX.RESULTSOverall, 7 RCTs involving 3168 patients, including 7 biologic agents, met the inclusion criteria. The NI-071 was listed at the top left of the diagonal of the league table because it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate. SB2 was listed at the bottom right of the diagonal of the league table because it was associated with the least favorable results. Based on SUCRA, NI-071 had the highest probability of being the best treatment agent in terms of the ACR20 response rate (SUCRA = 0.731), followed by ABP 710, CT-P13, BCD-055, infliximab, Exemptia, PF-06438179, and SB2 (SUCRA = 0.311). Although statistically non-significant differences in safety ranking were observed for serious adverse events (SAEs) among the treatment options, ABP 710 presented the highest safety probability (SUCRA = 0.739) while BCD-055 showed the lowest safety profile (SUCRA = 0.289).CONCLUSIONNo significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations.

02 Nov 2019·Modern 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

Objectives: This study aimed to demonstrate the equivalence of NI-071, an infliximab biosimilar (BS), and the infliximab reference product (RP) for treating Japanese patients with active rheumatoid arthritis (RA) refractory to methotrexate.Methods: In this multicenter two-period phase III study, patients were treated with BS or RP for 30 weeks (Period I) in a randomized double-blind manner and then with BS for the following 24 weeks (Period II). The efficacy and safety of BS and RP were compared.Results: The disease activity score in 28-joint count based on erythrocyte sedimentation rate or C-reactive protein and the American College of Rheumatology 20/50/70-based efficacy profiles of BS were similar to those of RP during Period I (30 weeks) including evaluations at week 14, a critical time point. BS efficacy was maintained throughout the 54-week study period. BS efficacy profile matched the RP profile until week 54 after the drug switch from RP to BS at week 30. The safety profiles of BS and RP were comparable and the long-term safety of BS was confirmed.Conclusion: BS demonstrated equivalent efficacy and safety to RP at treatment weeks 14 and 30, and long-term safety until week 54 in Japanese RA patients.

01 May 2010·Praxis

Schweizerisches Register für TNF-α-Blocker bei Kindern und Jugendlichen mit rheumatologischen Erkrankungen

Article

Author: Sauvain ; Schalm ; Hofer ; Kaiser ; Bérthet ; Bolt ; Bolz ; Saurenmann ; Cannizzaro

100 Deals associated with Infliximab(Nichi-Iko Pharmaceutical)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D02598	-	L04AB02	DB00065

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Crohn Disease	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Erythrodermic psoriasis	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Psoriasis vulgaris	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Pustular psoriasis	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Rheumatoid Arthritis	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Ankylosing Spondylitis	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017
Arthritis, Psoriatic	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017
Behcet's uveitis	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Preclinical	Puerto Rico	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	United States	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	Ukraine	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	Russia	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	Czechia	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	Spain	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	Poland	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Preclinical	United Kingdom	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02990806 (CTgov)	Phase 3	Rheumatoid Arthritis	683	Remicade (Stage 1: Remicade-US Group)	rqpmjzmssy(zgqhttcxjs) = novmdbooxm ehygnbgjmy (jwmzdnxjyd, tdtrelajtj - rwomrlrewn) View more	-	25 Jan 2023
				Remicade (Stage 2 and Stage 3: Remicade US to Remicade-US Group)	snrposxxfp(znmyrsvcql) = astefsgczl wixbkkwprj (itkquadpmk, sspexehqwr - eqzxyaclgv) View more
NCT01927263 (Pubmed \| Isr Med Assoc J) Manual	Phase 3	Rheumatoid Arthritis	242	NI-071	usvxbmgpxp(dcckegdtzd) = BS demonstrated equivalent efficacy to RP at treatment weeks 14 and 30, sahpjzyrxo (bxptjlypbk ) View more	Positive	01 Nov 2019
				Infliximab

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

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.

login

or

view full example data

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

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Infliximab(Nichi-Iko Pharmaceutical)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation