Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Ferdinando D’Amico
# ,
Virginia Solitano
# ORCID logo ,
Fernando Magro
,
Pablo A. Olivera
,
Jonas Halfvarson
,
David T. Rubin
,
Axel Dignass
,
Sameer Al Awadhi
,
Taku Kobayashi
,
Natalia Sousa Freitas Queiroz
ORCID logo ,
Marta Calvo
,
Paulo Gustavo Kotze
ORCID logo ,
Subrata Ghosh
ORCID logo ,
Laurent Peyrin-Biroulet
,
Silvio Danese
* ORCID logo
#
Equally contributing to the paper
Version 1 : Received: 30 August 2023 / Approved: 30 August 2023 / Online: 31 August 2023 (02:41:46 CEST)

A peer-reviewed article of this Preprint also exists.

D’Amico, F.; Solitano, V.; Magro, F.; Olivera, P.A.; Halfvarson, J.; Rubin, D.; Dignass, A.; Al Awadhi, S.; Kobayashi, T.; Queiroz, N.S.F.; Calvo, M.; Kotze, P.G.; Ghosh, S.; Peyrin-Biroulet, L.; Danese, S. Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus. J. Clin. Med. 2023, 12, 6350. D’Amico, F.; Solitano, V.; Magro, F.; Olivera, P.A.; Halfvarson, J.; Rubin, D.; Dignass, A.; Al Awadhi, S.; Kobayashi, T.; Queiroz, N.S.F.; Calvo, M.; Kotze, P.G.; Ghosh, S.; Peyrin-Biroulet, L.; Danese, S. Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus. J. Clin. Med. 2023, 12, 6350.

Abstract

While biologic originators’ patents are expiring, biosimilars are emerging to take their place, offering significant cost savings to healthcare systems. Many challenges still need to be addressed in the clinical practice of inflammatory bowel disease (IBD). A global survey was organized to highlight physicians’ current knowledge and beliefs and to gain insight about their practical management and remaining concerns and obstacles associated with starting a biosimilar, switching from an originator to a biosimilar, or switching from one biosimilar to another (multiple switches and reverse switching). 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. Consensus was reached on 10 statements regarding biosimilar effectiveness, safety, indications and rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching and future perspectives.

Keywords

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

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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