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

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infimab, Infliximab biosimilar, BOW-015

+ [1]

Target

TNF-α

Action

inhibitors

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-

Login to view timeline

Structure/Sequence

Sequence Code 69035L

The sequence is quoted from: *****

Sequence Code 69038H

The sequence is quoted from: *****

Infliximab 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).

METHODS:

We 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.

CONCLUSIONS:

Clinical 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·International journal of clinical pharmacology and therapeuticsQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

OBJECTIVES:

To 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.

METHODS:

In 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.

RESULTS:

Of 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.

CONCLUSIONS:

Bioequivalence 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)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	-

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	India	-	-

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2017	Phase 3	Ankylosing Spondylitis	68	BOW015	jncnrbmjnb(ysrzvjjgro) = sswbowaclw zyikpkjcjk (cbupkjnmwq ) View more	Positive	14 Jun 2017
EULAR2015	Phase 1	-	-	BOW015	ssnmchyvgs(yppiglzwvp) = scluqijdqz rezwbsxkpb (sqhraovwvl )	-	10 Jun 2015
				Reference infliximab (rIFX)	ssnmchyvgs(yppiglzwvp) = mlhgrtcpza rezwbsxkpb (sqhraovwvl )
EULAR2014	Phase 3	Rheumatoid Arthritis CRP ≥10 mg/L \| TB by PPD \| QuantiFERON-TB Gold ... View more	189	BOW015	nnvvyysblp(vltblbyxif) = qiinhgcnjd jseyguyjsk (zgdfzfnuiw ) View more	Positive	11 Jun 2014
				Innovator IFX (iIFX)	nnvvyysblp(vltblbyxif) = hyrdupgvkn jseyguyjsk (zgdfzfnuiw ) View more

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 biosimilar (EPIRUS Biopharma)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation