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

D'Amico, Ferdinando (author)
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
Solitano, Virginia (author)
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
Magro, Fernando (author)
CINTESIS@RISE, Faculty of Medicine of the University of Porto, 4200-319 Porto, Portugal
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Olivera, Pablo A. (author)
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
Halfvarson, Jonas, 1970- (author)
Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
Rubin, David (author)
The University of Chicago Medicine Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL 60637, USA
Dignass, Axel (author)
Department of Medicine I, Agaplesion Markus Hospital, Goethe University, 60323 Frankfurt am Main, Germany
Al Awadhi, Sameer (author)
Digestive Diseases Unit, Rashid Hospital, Dubai P.O. Box 4545, United Arab Emirates
Kobayashi, Taku (author)
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo 108-8642, Japan
Queiroz, Natália Sousa Freitas (author)
Health Sciences Graduate Program, School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil
Calvo, Marta (author)
IBD Unit, Gastroenterology, Hospital Universitario Puerta de Hierro Majalahonda, 28222 Madrid, Spain
Kotze, Paulo Gustavo (author)
Colorectal Surgery Unit, Hospital Universitário Cajuru, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil
Ghosh, Subrata (author)
APC Microbiome Ireland, College of Medicine and Health, University College Cork, T12 E138 Cork, Ireland
Peyrin-Biroulet, Laurent (author)
Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; Inserm, NGERE, University of Lorraine, F-54000 Vandœuvre-lès-Nancy, France; INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; Groupe Hospitalier Privé Ambroise Paré-Hartmann, Paris IBD Center, F-92200 Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC H4A 3J1, Canada
Danese, Silvio (author)
Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, 20132 Milan, Italy
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 (creator_code:org_t)
MDPI, 2023
2023
English.
In: Journal of Clinical Medicine. - : MDPI. - 2077-0383. ; 12:19
  • Journal article (peer-reviewed)
Abstract Subject headings
Close  
  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)

Keyword

Crohn’s disease
IBD
bio-originators
biologic drug
biosimilars
economics
interchangeability
ulcerative colitis

Publication and Content Type

ref (subject category)
art (subject category)

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