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Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians’ current knowledge, belief...

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Autores principales: D’Amico, Ferdinando, Solitano, Virginia, Magro, Fernando, Olivera, Pablo A., Halfvarson, Jonas, Rubin, David, Dignass, Axel, Al Awadhi, Sameer, Kobayashi, Taku, Queiroz, Natália Sousa Freitas, Calvo, Marta, Kotze, Paulo Gustavo, Ghosh, Subrata, Peyrin-Biroulet, Laurent, Danese, Silvio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10574001/
https://www.ncbi.nlm.nih.gov/pubmed/37834994
http://dx.doi.org/10.3390/jcm12196350
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author D’Amico, Ferdinando
Solitano, Virginia
Magro, Fernando
Olivera, Pablo A.
Halfvarson, Jonas
Rubin, David
Dignass, Axel
Al Awadhi, Sameer
Kobayashi, Taku
Queiroz, Natália Sousa Freitas
Calvo, Marta
Kotze, Paulo Gustavo
Ghosh, Subrata
Peyrin-Biroulet, Laurent
Danese, Silvio
author_facet D’Amico, Ferdinando
Solitano, Virginia
Magro, Fernando
Olivera, Pablo A.
Halfvarson, Jonas
Rubin, David
Dignass, Axel
Al Awadhi, Sameer
Kobayashi, Taku
Queiroz, Natália Sousa Freitas
Calvo, Marta
Kotze, Paulo Gustavo
Ghosh, Subrata
Peyrin-Biroulet, Laurent
Danese, Silvio
author_sort D’Amico, Ferdinando
collection PubMed
description As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians’ current knowledge, beliefs, practical approaches, and concerns related to biosimilar adoption—whether initiating a biosimilar, transitioning from an originator to a biosimilar, or switching between biosimilars (including multiple switches and reverse switching)—a global survey was conducted. Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. This consensus centered on 10 key statements covering biosimilar effectiveness, safety, indications, rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching, and future perspectives. Ultimately, the consensus affirmed that biosimilars are equally effective and safe when compared to originator drugs. They are considered suitable for both biologic-naïve patients and those who have previously been treated with originator drugs, with cost reduction being the primary motivation for transitioning from an originator drug to a biosimilar.
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spelling pubmed-105740012023-10-14 Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus D’Amico, Ferdinando Solitano, Virginia Magro, Fernando Olivera, Pablo A. Halfvarson, Jonas Rubin, David Dignass, Axel Al Awadhi, Sameer Kobayashi, Taku Queiroz, Natália Sousa Freitas Calvo, Marta Kotze, Paulo Gustavo Ghosh, Subrata Peyrin-Biroulet, Laurent Danese, Silvio J Clin Med Article As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians’ current knowledge, beliefs, practical approaches, and concerns related to biosimilar adoption—whether initiating a biosimilar, transitioning from an originator to a biosimilar, or switching between biosimilars (including multiple switches and reverse switching)—a global survey was conducted. Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. This consensus centered on 10 key statements covering biosimilar effectiveness, safety, indications, rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching, and future perspectives. Ultimately, the consensus affirmed that biosimilars are equally effective and safe when compared to originator drugs. They are considered suitable for both biologic-naïve patients and those who have previously been treated with originator drugs, with cost reduction being the primary motivation for transitioning from an originator drug to a biosimilar. MDPI 2023-10-03 /pmc/articles/PMC10574001/ /pubmed/37834994 http://dx.doi.org/10.3390/jcm12196350 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
D’Amico, Ferdinando
Solitano, Virginia
Magro, Fernando
Olivera, Pablo A.
Halfvarson, Jonas
Rubin, David
Dignass, Axel
Al Awadhi, Sameer
Kobayashi, Taku
Queiroz, Natália Sousa Freitas
Calvo, Marta
Kotze, Paulo Gustavo
Ghosh, Subrata
Peyrin-Biroulet, Laurent
Danese, Silvio
Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title_full Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title_fullStr Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title_full_unstemmed Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title_short Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
title_sort practical management of biosimilar use in inflammatory bowel disease (ibd): a global survey and an international delphi consensus
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10574001/
https://www.ncbi.nlm.nih.gov/pubmed/37834994
http://dx.doi.org/10.3390/jcm12196350
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