Biosimilar switching in inflammatory bowel disease: from evidence to clinical practice.

INTRODUCTION: After patents' expiration of biological originators, several biosimilars of infliximab and adalimumab have been authorized. The approval is based on data extrapolated from other indications for which the originator has been previously tested. Despite rigorous approval processes by regulatory entities, physicians' and patients' knowledge about biosimilars is limited and some concerns about their use persist. AREAS COVERED: This article summarizes the evidence on efficacy, safety, and immunogenicity of biosimilars currently approved in Europe for IBD treatment, by reviewing the literature on PubMed, EMBASE, and Web of Science databases up to mid-July 2020. Particular emphasis was placed on the need to further improve communication with patients and physicians' knowledge on biosimilars. EXPERT OPINION: Adoption of biosimilars in clinical practice represents a great opportunity from an economic point of view, reducing healthcare costs and increasing patients' access to effective biologic treatments. Clinicians should be aware and confident of the latest evidence on available biosimilars and be very careful in communicating information to patients. Nocebo effect should not be overlooked since it can negatively influence outcomes of biosimilar-treated subjects, limiting the wide use of biosimilars. Evaluating the outcomes of reverse, multiple, and cross-switch will be a challenge for the next years.