Introduction: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naïve patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars. Area covered: We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient-physician communication and need for shared decision-making. Expert opinion: The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.

Department of Gastroenterology and EC2M3 EA7375 Unit Assistance Publique Hôpitaux de Paris Paris Est Creteil University Henri Mondor Hospital Creteil France

Dermatology Department 2nd Medical faculty Charles University and Na Bulovce Hospital Prague Czech Republic

Fresenius Kabi SwissBioSim GmbH Eysins Switzerland

NIHR Clinical Research Facility University Hospital Southampton NHS Foundation Trust Southampton UK

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