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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Oxford University Press
2021
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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 |
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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 |
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