Delving into the Latest Updates on Infliximab biosimilar (EPIRUS Biopharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infimab, Infliximab biosimilar

+ [1]

Target

TNF-α

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Rheumatoid Arthritis

Inactive Indication-

Originator Organization

EPIRUS Biopharmaceuticals, Inc.

Active Organization-

Inactive Organization

Epirus Biopharmaceuticals (Switzerland) GmbH

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 69035L

The sequence is quoted from: *****

Sequence Code 69038H

The sequence is quoted from: *****

The arena of uveitis deals with a number of entities, which can be infectious or immune mediated. Noninfectious uveitis (NIU) has been managed with corticosteroids and immunosuppressives. However, their prolonged use has side effects limiting clinical utility in the long run. Improved knowledge regarding pathogenesis of uveitis and associated systemic disease has led to a new epoch in the development of treatment strategies, of which biologics are the recent ones. Biologics revolutionized the management of NIU especially uveitis associated with spondyloarthropathy and refractory uveitis. They target inflammation at a molecular level with less side effects. The most widely used are tumor necrosis factor-alpha inhibitors (infliximab and adalimumab). Other drugs include anti-CD20 inhibitors (rituximab), interleukin-6R-inhibitor (tocilizumab), Interleukin-1R-inhibitor (anakinra), Iinterleukin-2-inhibitor (daclizumab), and the list is further increasing. New advances in biologics are the biosimilar molecules, which are biological products that are highly similar to the reference product, and they include Infimab (biosimilar of infliximab), Exemptia or Adfrar (biosimilar of adalimumab), and Intacept or Etacept (biosimilar of etanercept). Other group of biologics are Janus Associated Kinase inhibitors (JAK-inhibitors), which are long-term oral treatment options of rheumatoid arthritis. They inhibit JAKs, which cause activation of signal transducer and activator of transcription (STAT) proteins, and initiate transcription of inflammatory genes. Many inflammatory cytokines that are implicated in pathogenesis of ocular inflammation are known to utilize the JAK/STAT-signaling pathway, including interleukin-2 (IL-2) and IL-6. Thus, biologics are the future of uveitis treatment with promising results. This article aims to summarize the current knowledge on biologics and their clinical utility in the management of NIU.

15 Feb 2018·Current Pharmaceutical DesignQ4 · MEDICINE

The Experience with Biosimilars of Infliximab in Rheumatic Diseases

Q4 · MEDICINE

Review

Author: Kos, Igor Age ; Azevedo, Valderilio Feijo ; Ariello, Leonardo

BACKGROUNDInfliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) and BOW015 (Epirus).METHODSWe have made a literature search in MedLine database using the key words [Infliximab] and [biosimilars] and [rheumatic diseases] and [rheumatisms]. We have also made a search in the clinicaltrials.org website.CONCLUSIONSClinical data published so far have provided important evidence on long-term efficacy and safety, immunogenicity and switching, supporting the use of CT-P13 and SB2 for the treatment of rheumatic diseases. In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars.

01 Apr 2016·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Bioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximab

Q4 · MEDICINE

Article

Author: Kay, Jonathan ; Knight, Alastair ; Thomson, Elizabeth ; Willers, Joerg ; Wyand, Michael ; Lambert, John ; Shneyer, Lucy ; Lassen, Cheryl

OBJECTIVESTo compare the single-dose pharmacokinetics (PK), safety, and immunogenicity of the biosimilar infliximab (BOW015) to reference infliximab (rIFX) in healthy volunteers and to establish bioequivalence.METHODSIn this randomized, double-blind, parallel-group, single-dose study, subjects received either BOW015 or rIFX. Both drugs were administered as a single IV 5 mg/kg dose over 2 hours on day 1. PK sampling occurred 10 times over 3 days and during safety and immunogenicity follow-up on day 4 and 1, 2, 3, 5, 7, 9, and 12 weeks after the infusion.RESULTSOf the 84 healthy male Caucasian subjects randomized, 43 received BOW015 and 41 received rIFX. PK parameters (geometric mean) for BOW015 vs. rIFX were as follows; C(max) 142.47 vs. 126.74 μg/mL, AUC(0-t) 36,211 vs. 34,304 h×μg/mL, and AUC(0-inf) 36,775 vs. 34,801 h×μg/mL. The point estimates of the BOW015/rIFX geometric mean ratios (90% CI) were; C(max) 1.13 (1.07 - 1.18), AUC(0-t) 1.06 (0.98 - 1.14), and AUC(0-inf) 1.06 (0.98 - 1.15). Overall, anti-drug antibodies were detected in 18.6% of BOW015-treated subjects and 24.4% of rIFX-treated subjects. A total of 26 (60.5%) subjects in the BOW015 group reported 50 treatment-emergent adverse events (TEAEs) and 27 (65.9%) subjects in the rIFX group reported 54 TEAEs.CONCLUSIONSBioequivalence of BOW015 to rIFX is demonstrated as 90% CIs for the study drug mean ratios of C(max), AUC(0-t), and AUC(0-inf) were within the log-transformed ± 20% equivalence range of 0.80 - 1.25. Safety and immunogenicity were also comparable.

1

News (Medical) associated with Infliximab biosimilar (EPIRUS Biopharma)

14 Apr 2021

·www.globenewswire.com

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

BiosimilarAntibody

100 Deals associated with Infliximab biosimilar (EPIRUS Biopharma)

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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
Rheumatoid Arthritis	IN	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Discovery	-	Epirus Biopharmaceuticals (Switzerland) GmbH	01 Feb 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2017	Phase 3	Ankylosing Spondylitis	68	BOW015	(rjvkhwyvnb) = tutbrlucay jtqgyxlqfa (shdzwyocmy ) View more	Positive	14 Jun 2017
EULAR2015	Phase 1	-	-	BOW015	(jfpgupvkwt) = wjxadpvfsw oirebjelre (fgcylxaoek )	-	10 Jun 2015
				Reference infliximab (rIFX)	(jfpgupvkwt) = idljbbtlwk oirebjelre (fgcylxaoek )
EULAR2014	Phase 3	Rheumatoid Arthritis CRP ≥10 mg/L \| TB by PPD \| QuantiFERON-TB Gold ... View more	189	BOW015	(zppkqsrogd) = pcosvkgdhv jokjhqhonp (rqryregmlz ) View more	Positive	11 Jun 2014
				Innovator IFX (iIFX)	(zppkqsrogd) = hfcumugpkg jokjhqhonp (rqryregmlz ) View more