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Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus
Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, 20132 Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy; Department of Medicine, Division of Gastroenterology, Schulich School of Medicine, Western University, London, ON N6A 3K7, Canada.
CINTESIS@RISE, Faculty of Medicine of the University of Porto, 4200-319 Porto, Portugal.
Gastroenterology Department, CEMIC, Buenos Aires C1425ASS, Argentina; Zane Cohen Centre for Digestive Diseases-Lunenfeld-Tanenbaum Research Institute-Sinai Health System-Gastroenterology, Toronto, ON M5T 3L9, Canada.
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2023 (English)In: Journal of Clinical Medicine, E-ISSN 2077-0383, Vol. 12, no 19, article id 6350Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
MDPI, 2023. Vol. 12, no 19, article id 6350
Keywords [en]
Crohn’s disease, IBD, bio-originators, biologic drug, biosimilars, economics, interchangeability, ulcerative colitis
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-108986DOI: 10.3390/jcm12196350ISI: 001094705100001PubMedID: 37834994Scopus ID: 2-s2.0-85173815239OAI: oai:DiVA.org:oru-108986DiVA, id: diva2:1805091
Note

The consensus was supported by Sandoz.

Available from: 2023-10-16 Created: 2023-10-16 Last updated: 2024-04-08Bibliographically approved

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