Cargando…

The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics

The relatively high cost of anti-TNF agents and looming or actual expiry of patents for several biologics have led to the development of “highly similar” versions of the “originator” drugs called “biosimilars.” The approval of biosimilars has been based on “extrapolation,” whereby approval is grante...

Descripción completa

Detalles Bibliográficos
Autores principales: Limdi, Jimmy K, Farraye, Francis A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802304/
https://www.ncbi.nlm.nih.gov/pubmed/36776664
http://dx.doi.org/10.1093/crocol/otab015
_version_ 1784861655262298112
author Limdi, Jimmy K
Farraye, Francis A
author_facet Limdi, Jimmy K
Farraye, Francis A
author_sort Limdi, Jimmy K
collection PubMed
description The relatively high cost of anti-TNF agents and looming or actual expiry of patents for several biologics have led to the development of “highly similar” versions of the “originator” drugs called “biosimilars.” The approval of biosimilars has been based on “extrapolation,” whereby approval is granted in licensed indications for the reference product without the need for clinical trials. We discuss efficacy and safety data in support of biosimilar use from prospective studies, switching from originator biologic, impact on immunogenicity, pharmaco-economic, and practical considerations for clinicians.
format Online
Article
Text
id pubmed-9802304
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-98023042023-02-10 The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics Limdi, Jimmy K Farraye, Francis A Crohns Colitis 360 Invited Reviews The relatively high cost of anti-TNF agents and looming or actual expiry of patents for several biologics have led to the development of “highly similar” versions of the “originator” drugs called “biosimilars.” The approval of biosimilars has been based on “extrapolation,” whereby approval is granted in licensed indications for the reference product without the need for clinical trials. We discuss efficacy and safety data in support of biosimilar use from prospective studies, switching from originator biologic, impact on immunogenicity, pharmaco-economic, and practical considerations for clinicians. Oxford University Press 2021-04-15 /pmc/articles/PMC9802304/ /pubmed/36776664 http://dx.doi.org/10.1093/crocol/otab015 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Invited Reviews
Limdi, Jimmy K
Farraye, Francis A
The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title_full The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title_fullStr The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title_full_unstemmed The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title_short The Great Debate With IBD Biosimilars: Pro: Biosimilars Should Be Routinely Used as a First Line Biologic and May Be Switched From Reference Biologics
title_sort great debate with ibd biosimilars: pro: biosimilars should be routinely used as a first line biologic and may be switched from reference biologics
topic Invited Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802304/
https://www.ncbi.nlm.nih.gov/pubmed/36776664
http://dx.doi.org/10.1093/crocol/otab015
work_keys_str_mv AT limdijimmyk thegreatdebatewithibdbiosimilarsprobiosimilarsshouldberoutinelyusedasafirstlinebiologicandmaybeswitchedfromreferencebiologics
AT farrayefrancisa thegreatdebatewithibdbiosimilarsprobiosimilarsshouldberoutinelyusedasafirstlinebiologicandmaybeswitchedfromreferencebiologics
AT limdijimmyk greatdebatewithibdbiosimilarsprobiosimilarsshouldberoutinelyusedasafirstlinebiologicandmaybeswitchedfromreferencebiologics
AT farrayefrancisa greatdebatewithibdbiosimilarsprobiosimilarsshouldberoutinelyusedasafirstlinebiologicandmaybeswitchedfromreferencebiologics