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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...

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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
Descripción
Sumario: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.