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

Author:

D’Amico Ferdinando12,Solitano Virginia23ORCID,Magro Fernando4,Olivera Pablo A.56ORCID,Halfvarson Jonas7ORCID,Rubin David8ORCID,Dignass Axel9,Al Awadhi Sameer10ORCID,Kobayashi Taku11,Queiroz Natália Sousa Freitas12ORCID,Calvo Marta13,Kotze Paulo Gustavo14ORCID,Ghosh Subrata15ORCID,Peyrin-Biroulet Laurent161718192021,Danese Silvio1ORCID

Affiliation:

1. Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, 20132 Milan, Italy

2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy

3. Department of Medicine, Division of Gastroenterology, Schulich School of Medicine, Western University, London, ON N6A 3K7, Canada

4. CINTESIS@RISE, Faculty of Medicine of the University of Porto, 4200-319 Porto, Portugal

5. Gastroenterology Department, CEMIC, Buenos Aires C1425ASS, Argentina

6. Zane Cohen Centre for Digestive Diseases-Lunenfeld-Tanenbaum Research Institute-Sinai Health System-Gastroenterology, Toronto, ON M5T 3L9, Canada

7. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, SE-701 82 Örebro, Sweden

8. The University of Chicago Medicine Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL 60637, USA

9. Department of Medicine I, Agaplesion Markus Hospital, Goethe University, 60323 Frankfurt am Main, Germany

10. Digestive Diseases Unit, Rashid Hospital, Dubai P.O. Box 4545, United Arab Emirates

11. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo 108-8642, Japan

12. Health Sciences Graduate Program, School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil

13. IBD Unit, Gastroenterology, Hospital Universitario Puerta de Hierro Majalahonda, 28222 Madrid, Spain

14. Colorectal Surgery Unit, Hospital Universitário Cajuru, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil

15. APC Microbiome Ireland, College of Medicine and Health, University College Cork, T12 E138 Cork, Ireland

16. Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France

17. Inserm, NGERE, University of Lorraine, F-54000 Vandœuvre-lès-Nancy, France

18. INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France

19. FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France

20. Groupe Hospitalier Privé Ambroise Paré-Hartmann, Paris IBD Center, F-92200 Neuilly sur Seine, France

21. Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC H4A 3J1, Canada

Abstract

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.

Funder

Sandoz

Publisher

MDPI AG

Subject

General Medicine

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