In the last 20 years, biological drugs have become the mainstream therapy for patients affected by moderately-to-severely active inflammatory bowel disease (IBD), even though they are associated with a significant increase in health-related costs. After the expiry of patents on originator drugs, the advent of antitumour necrosis factor alfa (TNF-α) biosimilars resulted in considerable cost-savings and increased patients’ access to these drugs. After having completed registration trials in rheumatic diseases [1, 2], the infliximab biosimilar CT P13 obtained approval based on a comprehensive comparability exercise, for all other indications, including IBD. Accordingly, physicians started to increasingly prescribe biosimilars for patients with IBD – including those that were both anti-TNF-α naïve and experienced. There is growing evidence that early introduction of biological therapy in IBD is associated with more favourable outcomes in the medium to long term. Keeping that in mind, it follows that the advent of biosimilars has the potential to allow more patients to have access to biological therapy at an earlier stage of disease, which could contribute to prevent disease progression and damage accumulation, with a consequential improvement in patients’ quality of life.
Since biosimilars commercialization, patients on maintenance therapy with the reference products have been increasingly ‘switched’ to biosimilars, with significant cost savings  Since no differences have been observed in terms of efficacy and safety between reference products and their biosimilars , ‘non-medical switching’ has been performed in recent years. With regards to biosimilars, non-medical switching can be defined as the decision, not driven by specific medical reasons, of switching to a biosimilar in clinically stable patients. Such practice has been extensively tested in both clinical trials and real-life studies and, to date, is regarded as part of the standard-of-care for patients treated with biotechnological drugs. It is usually performed due to economic reasons, since it can allow significant cost savings.
The objective of this  and similar studies was to explore the safety, effectiveness and immunogenicity of switching from originator infliximab to CT P13 for IBD patients. The experience of Pugliese et al. confirmed, after one year of follow-up, in a large cohort of IBD patients in stable remission, that switching to CT-P13 did not significantly impact on persistence on therapy, steroid-free clinical remission and biochemical remission. Moreover, the rate of adverse events and of development of persistent anti-drug antibodies (responsible for loss of response) were quite low and similar to those reported with originator infliximab.
This is one of the largest prospective real-life experiences monitoring clinical, biochemical and pharmacokinetic parameters in a cohort of IBD patients switched from originator infliximab to CT-P13 and shows that switching does not increase infliximab immunogenicity and does not affect persistence on therapy. Interestingly, in the cohort tested, a significant reduction in the proportion of patients in steroid-free clinical remission just after the switch was observed. Such a clinical deterioration was not accompanied by any change in mean C-reactive protein levels nor mean infliximab trough levels and was not observed at subsequent study visits and could therefore be framed as a transient nocebo effect. As a matter of fact, it has already been reported in previous works that biosimilar switching might be associated with a nocebo effect . The nocebo effect is defined as ‘psychological, physiological and neurobiological phenomena associated with actual or perceived harm that occur as a consequence of patients’ negative expectations, psychosocial context and therapeutic environment, not the known pharmacological actions of treatment’. With regard to biosimilars, it has been noted that the nocebo effect can negatively impact treatment persistence in cases of non-medical switching .
Conflict of interest
The authors of the research paper  reported conflict of interest, including having received consultancy fees, speaker fees, advisory board fees and research grants from pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Daniela Pugliese, CEMAD – IBD UNIT – Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario ‘A Gemelli’ IRCCS , Rome, Italy.
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Discontinuation following biosimilar switching in IBD patients
International policies for interchangeability, switching and substitution of biosimilars
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6. D'Amico F, Pouillon L, Argollo M, et al. Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: results of a workshop from the NOCE-BIO consensus group. Dig Liver Dis. 2020;52(2):138-42.
7. Boone NW, Liu L, Romberg-Camps MJ, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74(5):655-61.
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