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Biosimilars in Pediatric IBD: Updated Considerations for Disease Management

Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expi...

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Detalles Bibliográficos
Autores principales: Dipasquale, Valeria, Cucinotta, Ugo, Romano, Claudio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9205321/
https://www.ncbi.nlm.nih.gov/pubmed/35721798
http://dx.doi.org/10.2147/BTT.S367032
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author Dipasquale, Valeria
Cucinotta, Ugo
Romano, Claudio
author_facet Dipasquale, Valeria
Cucinotta, Ugo
Romano, Claudio
author_sort Dipasquale, Valeria
collection PubMed
description Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expired, the development and commercialization of biosimilars through abbreviated licensing pathways represented an affordable alternative in patients fulfilling the indication for biologics. A growing body of evidence, first in adults and then in the pediatric age group too, has provided reassuring data in terms of efficacy and safety of biosimilars both in naïve patients and in those previously on reference drugs who had to switch to the biosimilar. This review summarizes the currently available evidence for biosimilar use in IBD, with a focus on pediatric IBD. The most common practical approaches to biosimilar use in the pediatric clinical settings are also discussed.
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spelling pubmed-92053212022-06-18 Biosimilars in Pediatric IBD: Updated Considerations for Disease Management Dipasquale, Valeria Cucinotta, Ugo Romano, Claudio Biologics Review Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expired, the development and commercialization of biosimilars through abbreviated licensing pathways represented an affordable alternative in patients fulfilling the indication for biologics. A growing body of evidence, first in adults and then in the pediatric age group too, has provided reassuring data in terms of efficacy and safety of biosimilars both in naïve patients and in those previously on reference drugs who had to switch to the biosimilar. This review summarizes the currently available evidence for biosimilar use in IBD, with a focus on pediatric IBD. The most common practical approaches to biosimilar use in the pediatric clinical settings are also discussed. Dove 2022-06-13 /pmc/articles/PMC9205321/ /pubmed/35721798 http://dx.doi.org/10.2147/BTT.S367032 Text en © 2022 Dipasquale et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Review
Dipasquale, Valeria
Cucinotta, Ugo
Romano, Claudio
Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title_full Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title_fullStr Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title_full_unstemmed Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title_short Biosimilars in Pediatric IBD: Updated Considerations for Disease Management
title_sort biosimilars in pediatric ibd: updated considerations for disease management
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9205321/
https://www.ncbi.nlm.nih.gov/pubmed/35721798
http://dx.doi.org/10.2147/BTT.S367032
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