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Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of swit...

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Autores principales: Moots, Robert, Azevedo, Valderilio, Coindreau, Javier L., Dörner, Thomas, Mahgoub, Ehab, Mysler, Eduardo, Scheinberg, Morton, Marshall, Lisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486595/
https://www.ncbi.nlm.nih.gov/pubmed/28623625
http://dx.doi.org/10.1007/s11926-017-0658-4
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author Moots, Robert
Azevedo, Valderilio
Coindreau, Javier L.
Dörner, Thomas
Mahgoub, Ehab
Mysler, Eduardo
Scheinberg, Morton
Marshall, Lisa
author_facet Moots, Robert
Azevedo, Valderilio
Coindreau, Javier L.
Dörner, Thomas
Mahgoub, Ehab
Mysler, Eduardo
Scheinberg, Morton
Marshall, Lisa
author_sort Moots, Robert
collection PubMed
description PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2). Etanercept publications covered SB4 (2) and GP2015 (2). Adalimumab publications covered ABP 501 (2) and SB5 (1). Rituximab publications covered CT-P10 (1). Efficacy and safety data generally showed no differences between patients who switched treatments versus those who did not. No differences were seen pre- and post-switch. Immunogenicity data were presented in 19/37 (51%) studies. SUMMARY: Additional data from switching studies of these therapies are still required, as is continuing pharma-covigilance. Switching should remain a case-by-case clinical decision made by the physician and patient on an individual basis supported by scientific evidence. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11926-017-0658-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-54865952017-07-11 Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician Moots, Robert Azevedo, Valderilio Coindreau, Javier L. Dörner, Thomas Mahgoub, Ehab Mysler, Eduardo Scheinberg, Morton Marshall, Lisa Curr Rheumatol Rep Biosimilars (E Mysler, Section Editor) PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2). Etanercept publications covered SB4 (2) and GP2015 (2). Adalimumab publications covered ABP 501 (2) and SB5 (1). Rituximab publications covered CT-P10 (1). Efficacy and safety data generally showed no differences between patients who switched treatments versus those who did not. No differences were seen pre- and post-switch. Immunogenicity data were presented in 19/37 (51%) studies. SUMMARY: Additional data from switching studies of these therapies are still required, as is continuing pharma-covigilance. Switching should remain a case-by-case clinical decision made by the physician and patient on an individual basis supported by scientific evidence. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11926-017-0658-4) contains supplementary material, which is available to authorized users. Springer US 2017-06-16 2017 /pmc/articles/PMC5486595/ /pubmed/28623625 http://dx.doi.org/10.1007/s11926-017-0658-4 Text en © The Author(s) 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Biosimilars (E Mysler, Section Editor)
Moots, Robert
Azevedo, Valderilio
Coindreau, Javier L.
Dörner, Thomas
Mahgoub, Ehab
Mysler, Eduardo
Scheinberg, Morton
Marshall, Lisa
Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title_full Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title_fullStr Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title_full_unstemmed Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title_short Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician
title_sort switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician
topic Biosimilars (E Mysler, Section Editor)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486595/
https://www.ncbi.nlm.nih.gov/pubmed/28623625
http://dx.doi.org/10.1007/s11926-017-0658-4
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