Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease

Current Comfort and Future Prospects

Krisztina B. Gecse, P. Lakatos

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.

Original languageEnglish
Pages (from-to)1413-1420
Number of pages8
JournalDrugs
Volume76
Issue number15
DOIs
Publication statusPublished - Oct 1 2016

Fingerprint

Biosimilar Pharmaceuticals
Inflammatory Bowel Diseases
Monoclonal Antibodies
Safety
Phase III Clinical Trials
Clinical Trials, Phase I
Quality of Health Care
Ankylosing Spondylitis
Marketing
Legislation
Rheumatoid Arthritis
Industry

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease : Current Comfort and Future Prospects. / Gecse, Krisztina B.; Lakatos, P.

In: Drugs, Vol. 76, No. 15, 01.10.2016, p. 1413-1420.

Research output: Contribution to journalArticle

@article{16fcaa4b7e7c49e2b0084bd5c6304f51,
title = "Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects",
abstract = "Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.",
author = "Gecse, {Krisztina B.} and P. Lakatos",
year = "2016",
month = "10",
day = "1",
doi = "10.1007/s40265-016-0638-4",
language = "English",
volume = "76",
pages = "1413--1420",
journal = "Drugs",
issn = "0012-6667",
publisher = "Adis International Ltd",
number = "15",

}

TY - JOUR

T1 - Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease

T2 - Current Comfort and Future Prospects

AU - Gecse, Krisztina B.

AU - Lakatos, P.

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.

AB - Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.

UR - http://www.scopus.com/inward/record.url?scp=84987660547&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84987660547&partnerID=8YFLogxK

U2 - 10.1007/s40265-016-0638-4

DO - 10.1007/s40265-016-0638-4

M3 - Article

VL - 76

SP - 1413

EP - 1420

JO - Drugs

JF - Drugs

SN - 0012-6667

IS - 15

ER -