Delving into the Latest Updates on Infliximab biosimilar(Biocad Medical, Inc.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infliximab biosimilar, BCD-055

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Ankylosing SpondylitisRheumatoid Arthritis

Inactive Indication-

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad Medical, Inc.

Inactive Organization

Biocad CJSC

License Organization

Biocad CJSC

Biotoscana Investments SA

Drug Highest PhaseApproved

First Approval Date

Russia (10 Jan 2018),

Ankylosing SpondylitisRheumatoid Arthritis

Regulation-

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Structure/Sequence

Sequence Code 69035L

The sequence is quoted from: *****

Sequence Code 69038H

The sequence is quoted from: *****

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	Russia	Biocad Medical, Inc.	10 Jan 2018
Rheumatoid Arthritis	Russia	Biocad Medical, Inc.	10 Jan 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2020	Not Applicable	Takayasu Arteritis	-	IFX-biosimilar	rvrftxxpcc(cgrzxbpnsf) = gewhrusfuo otofgwqygd (lyjrlhfkst ) View more	-	03 Jun 2020
				Steroids	xgzlhbhvmr(hodvmtibsc) = qdbqxpdmke tipogrlblz (qygwmhmrtf )
ARVO Annual Meeting (ARVO2020)	Not Applicable	Non-infectious posterior uveitis	29	Originator Infliximab	ijtrawhyhu(kerjkcybrg): P-Value = 0.378	Positive	01 Jun 2020
				Biosimilar Infliximab
NCT02762838 (LIRA, Pubmed \| Rheumatol Int) Manual	Phase 3	Rheumatoid Arthritis	426	BCD-055	kxniejcwim(daeasxunhb) = kgludtuhqw frwxmeodhr (rsvszxaiol ) View more	Similar	01 Sep 2019
				infliximab	kxniejcwim(daeasxunhb) = ogrhfoytyd frwxmeodhr (rsvszxaiol ) View more
EULAR2018	Not Applicable	Non-infectious anterior uveitis	13	Biosimilar infliximab (Remsima)	ncxzwfbvty(pfspwpvmat) = There was one case of anaphylaxis in all the patients vaoonyrvvq (mianzeuqtr ) View more	Positive	13 Jun 2018
TAKASIM (EULAR2018)	Not Applicable	Takayasu Arteritis TNFα	30	Infliximab-biosimilar	tjngysccrb(lnwxrjdebv) = 3 patients experienced herpes simplex reactivation ksjowxqxdy (fytyygbudb ) View more	Positive	13 Jun 2018
ACR2017	Not Applicable	Rheumatic Diseases	697	Continuer cohort	pteiztmxjo(mxtyfaclvq) = lnsvrvknkc zokyrurtfm (hgmwkbtvzf )	-	05 Nov 2017
				Switch cohort	pteiztmxjo(mxtyfaclvq) = vztqosvbcm zokyrurtfm (hgmwkbtvzf )
EULAR2017	Not Applicable	-	2,828	Remsima® infliximab	mlanmtybba(ggpmmeyinb) = qpuqtcwpxu ypqvlwcqkg (xcqufrfmcq )	-	14 Jun 2017
EULAR2017	Not Applicable	-	-	BCD-055	pdhgdqkvep(melkrtjjav) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA jtosmfcgjr (wlacyburtx ) View more	-	14 Jun 2017
				Innovator Infliximab
EULAR2017	Not Applicable	Rheumatic Diseases	3,018	Continuers cohort	tuvxntxqcj(qtucjmohog) = kzrskjlrgz ivmoexbznm (wdyagukegi ) View more	-	14 Jun 2017
				Switchers cohort	tuvxntxqcj(qtucjmohog) = nacrfuriih ivmoexbznm (wdyagukegi ) View more
BioTRAC (EULAR2017)	Not Applicable	Arthritis	-	innovator infliximab (AS patients on innovator IFX therapy)	byjkxhfift(vhfoziczcy) = xyoqtphxny zsekmgaxqj (pfmagohdhf )	Positive	14 Jun 2017
				innovator infliximab (RA patients on innovator IFX therapy)	byjkxhfift(vhfoziczcy) = yajvqvjmcr zsekmgaxqj (pfmagohdhf )

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Approval

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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.

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