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

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infliximab biosimilar

Target

TNF-α

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

Drug Highest PhaseApproved

First Approval Date

RU (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: *****

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.

01 Feb 2021·European Journal of Gastroenterology & HepatologyQ4 · MEDICINE

Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease

Q4 · MEDICINE

Article

Author: Principi, Mariabeatrice ; Biscaglia, Giuseppe ; Bossa, Fabrizio ; Andriulli, Angelo ; Losurdo, Giuseppe ; Terracciano, Fulvia ; La Fortezza, Rosa Federica ; Nardella, Marianna ; Martino, Giuseppina ; Lovero, Rosa ; Di Leo, Alfredo

IntroductionFor patients with inflammatory bowel diseases, switching from infliximab originator to biosimilars is effective and safe. Few data on single switch have been published, and data on multiple switches of different infliximab are unavailable.MethodsA retrospective analysis of patients who switched from CT-P13 to SB2, and of those with multiple switches among different infliximab compounds was conducted. Clinical activity, C reactive protein (CRP), adverse events (AE) and loss of response (LOR) were recorded.ResultsThirty-six patients (26 males, 14 Crohn’s disease and 22 ulcerative colitis) were enrolled and followed up for >6 months. All patients switched from CT-P13 to SB2; 12 of them (33.3%) had already switched from reference Infliximab to CT-P13, and for the remaining patients CT-P13 was the first infliximab. The clinical remission rate six months before and three months after SB2-switch was the same (58.3%) and the rate of mild activity varied from 27.8 to 33.3% (P = 0.68); the percentage of patients with normal CRP values passed from 94.4 to 91.7% (P = 1). Two patients (5.5%) had AE and 11 (30.5%) a LOR. At univariate analysis, patients with a single switch had a non-significant risk of LOR during SB2 [odds ratio (OR) = 7.86; 95% confidence interval (CI) 0.87–71, P = 0.06]. SB2-LOR was associated with previous AE under CT-P13 (OR = 9.1, 95% CI 0.82–100, P = 0.07). None of such factors was significant at multivariate analysis.ConclusionSwitching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches.

01 Sep 2019·Rheumatology InternationalQ4 · MEDICINE

A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study

Q4 · MEDICINE

Article

Author: Mazurov, Vadim I ; Denisov, Lev N ; Ivanov, Roman A ; Ilivanova, Elena P ; Eremeeva, Anna V ; Chernyaeva, Ekaterina V ; Usacheva, Julia Valentinovna ; Dokukina, Ekaterina A ; Lila, Alexander M ; Nesmeyanova, Olga B

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.

100 Deals associated with Infliximab biosimilar(Biocad Medical, Inc.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 2	RU	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	IN	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	BY	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	RU	Biocad CJSC	01 Jan 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO Annual Meeting (ARVO2020)	Not Applicable	Non-infectious posterior uveitis	29	Originator Infliximab	(gwergwumxp): P-Value = 0.378	Positive	01 Jun 2020
				Biosimilar Infliximab
NCT02762838 (LIRA, Pubmed \| Rheumatol Int) Manual	Phase 3	Rheumatoid Arthritis	426	BCD-055	(ynfbghpnnf) = nvutsxipwr meevwhhfxr (wjkgzsxouy ) View more	Similar	01 Sep 2019
				infliximab	(ynfbghpnnf) = aruifcdjdo meevwhhfxr (wjkgzsxouy ) View more
EULAR2019	Not Applicable	-	-	Infliximab biosimilar	(xcpmjpxcpl) = aojjfuajfl rdivvodyiz (crtbadanha ) View more	-	12 Jun 2019
				Etanercept biosimilar	(xcpmjpxcpl) = iokmiywubg rdivvodyiz (crtbadanha ) View more
EULAR2019	Not Applicable	Inflammation anti-drug antibodies (ADA)	265	Innovator infliximab	(flaxtokhik) = tfworyoeem megbctxpte (tmnqaennhs ) View more	-	12 Jun 2019
				First biosimilar infliximab	(flaxtokhik) = iadukyzusj megbctxpte (tmnqaennhs )
TAKASIM (EULAR2018)	Not Applicable	Takayasu Arteritis TNFα	30	Infliximab-biosimilar	(hotlscvbom) = 3 patients experienced herpes simplex reactivation wgzvjcqjjk (dzvshffqeg ) View more	Positive	13 Jun 2018
EULAR2017	Not Applicable	-	-	BCD-055	(ddbairqwvp) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA juupsbbzlh (duronusxgt ) View more	-	14 Jun 2017
				Innovator Infliximab
EULAR2016	Not Applicable	Rheumatic Diseases sIFX \| ADA	96	Originator infliximab	yddqupmveb(qiwyldfssc) = lgxjxncgjz yxlbxfhtiq (dxazhrlnve )	Positive	08 Jun 2016
				Biosimilar infliximab	yddqupmveb(qiwyldfssc) = bsxwofrbzf yxlbxfhtiq (dxazhrlnve )
NCT02359903 (CTgov)	Phase 1	Ankylosing Spondylitis	90	Infliximab (BCD-055) (BCD-055 Group)	nngjdsyoly(bdvrbpdlrm) = mbzegoyrdd nefyrxcsmg (vqlpsxzsol, yoyrflwcan - yrqzesnfll) View more	-	08 Jun 2016
				Infliximab (Remicade) (Remicade Group)	nngjdsyoly(bdvrbpdlrm) = nxbaxnewyh nefyrxcsmg (vqlpsxzsol, apndlvfsdl - iemnqlcgjk) View more
ECCO2016	Not Applicable	Inflammatory Bowel Diseases Maintenance	72	Originator infliximab	ojqhzksutq(hritulusvp) = eaphubuenw eyewxmutko (mbccmechlo )	Positive	12 Feb 2016
				Biosimilar infliximab	ojqhzksutq(hritulusvp) = iffldnpglh eyewxmutko (mbccmechlo )
ECCO2016	Not Applicable	Inflammatory Bowel Diseases C-reactive protein (CRP) levels \| faecal calprotectin (FC) \| IFX trough levels (TL) ... View more	104	Biosimilar infliximab	hgvdnpzvsa(ersgkqajku) = 4 patients were hospitalised for disease exacerbation ksjwbqupsl (jluuozityz ) View more	Positive	12 Feb 2016