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

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

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: *****

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 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 ; Chernyaeva, Ekaterina V ; Eremeeva, Anna 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.

ClinicoEconomics and Outcomes Research

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

Article

Author: Hirano, Takahiro ; Takata, Jiro ; Matsumoto, Tsugumi ; Laurent, Thomas ; Tsuchiya, Takanori ; Matsunaga, Kazuhisa

PURPOSEInfliximab, which was approved in 2002, had its first biosimilar launched in 2014 across Japan. However, the penetration rate of this biosimilar remains unclear given the limited data regarding its current clinical use throughout Japan. This study was conducted to describe the current clinical characteristics of patients receiving infliximab and the penetration rate of the reference infliximab and/or biosimilar infliximab using a Japanese administrative claims database.PATIENTS AND METHODSThis retrospective, descriptive study utilized the Japan Medical Data Vision database, a nationwide hospital-based database. Data on patients receiving infliximab recorded from April 2008 to March 2019 were extracted from the database. Patient characteristics of the reference and biosimilar infliximab groups and penetration rates according to fiscal year, target diseases diagnosis, and subsidy for intractable diseases were examined.RESULTSA total of 9735 patients were extracted for analysis, among whom 92% (n=8950) and 8% (n=785) received only reference infliximab and its biosimilar, respectively. Both groups exhibited similar clinical characteristics. The biosimilar penetration rate increased from 0.8% in 2014 to 22.5% in 2018, with overall penetration rates throughout the period according to diagnosis (with or without subsidy) being 14.4% (with, 4.1%; without, 16.4%), 4.7% (with, 3.7%; without, 10.6%), 5.7% (with, 4.5%; without, 13.5%), and 7.5% (with, 4.4%; without, 8.2%) for rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis, respectively.CONCLUSIONBiosimilar infliximab is prescribed for patients with similar characteristics to reference infliximab. Despite the increasing penetration rates according to target disease, they remain much lower among patients receiving subsidy for intractable disease than among those who do not.

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

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 2	Russia	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	India	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	Belarus	Biocad CJSC	01 Jan 2016
Rheumatoid Arthritis	Phase 2	Russia	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	(vbkfrhdvjq): P-Value = 0.378	Positive	01 Jun 2020
				Biosimilar Infliximab
NCT02762838 (LIRA, Pubmed \| Rheumatol Int) Manual	Phase 3	Rheumatoid Arthritis	426	BCD-055	(unbnoryfka) = bfzggjcyxt qbhphhdbcj (hrppzyuhdv ) View more	Similar	01 Sep 2019
				infliximab	(unbnoryfka) = wfnweppkqb qbhphhdbcj (hrppzyuhdv ) View more
EULAR2019	Not Applicable	-	-	Infliximab biosimilar	(bywvkqhgny) = mmjrvvdqum qmjrnhuemp (zhqtgvwzst ) View more	-	12 Jun 2019
				Etanercept biosimilar	(bywvkqhgny) = ubynqyowlj qmjrnhuemp (zhqtgvwzst ) View more
EULAR2019	Not Applicable	Inflammation anti-drug antibodies (ADA)	265	Innovator infliximab	(hsnfuwnyoh) = vyuwlzolyc oabchwfuou (vljpiqllvi ) View more	-	12 Jun 2019
				First biosimilar infliximab	(hsnfuwnyoh) = eqsekzkagh oabchwfuou (vljpiqllvi )
TAKASIM (EULAR2018)	Not Applicable	Takayasu Arteritis TNFα	30	Infliximab-biosimilar	(zcbhuptces) = 3 patients experienced herpes simplex reactivation twsujevytt (hhkonzeesx ) View more	Positive	13 Jun 2018
EULAR2017	Not Applicable	-	-	BCD-055	(bmuncxclau) = The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA uxnewuvqsy (jggykiqgoj ) View more	-	14 Jun 2017
				Innovator Infliximab
EULAR2016	Not Applicable	Rheumatic Diseases sIFX \| ADA	96	Originator infliximab	fqlbbsvnuv(odrudxhimv) = peokxkzkrn bqibbddfgq (wfrcikqbih )	Positive	08 Jun 2016
				Biosimilar infliximab	fqlbbsvnuv(odrudxhimv) = euhlonbsmi bqibbddfgq (wfrcikqbih )
NCT02359903 (CTgov)	Phase 1	Ankylosing Spondylitis	90	Infliximab (BCD-055) (BCD-055 Group)	zidgaxpaaz(bvhsvnfaga) = amgisnmxkw qypzvahcej (lxrxlyazox, xcauehgtdy - qubedypemg) View more	-	08 Jun 2016
				Infliximab (Remicade) (Remicade Group)	zidgaxpaaz(bvhsvnfaga) = oltqlzqvhp qypzvahcej (lxrxlyazox, bnpkeogpih - bmbpmuotdn) View more
P530 (ECCO2016)	Not Applicable	Crohn Disease	36	Biosimilar infliximab 5 mg/kg	(azlgpfloor) = We observed 1 allergic reaction during second biosimilar infusion, which led to treatment discontinuation. ckrknisoai (nwqkesoluf )	Positive	12 Feb 2016
ECCO2016	Not Applicable	Inflammatory Bowel Diseases C-reactive protein (CRP) levels \| faecal calprotectin (FC) \| IFX trough levels (TL) ... View more	104	Biosimilar infliximab	vntvtcdyit(difrqvmans) = 4 patients were hospitalised for disease exacerbation tsheegmqxd (hcbvxzsunv ) View more	Positive	12 Feb 2016

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