Infliximab biosimilars for IBD patients: experience from Italy

Biosimilars/Research | Posted 12/03/2021 post-comment0 Post your comment

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 [3] Since no differences have been observed in terms of efficacy and safety between reference products and their biosimilars [4], ‘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 [5] 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 [6]. 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 [7].

Conflict of interest
The authors of the research paper [5] 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 [5].

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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International policies for interchangeability, switching and substitution of biosimilars


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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1. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72(10):1613-20.
2. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605-12.
3. Razanskaite V, Bettey M, Downey L, et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme. J Crohns Colitis. 2017;11(6):690-6.
4. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304-16.
5. Pugliese D, Guidi L, Privitera G, et al. Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients. Expert Opin Biol Ther. 2021;21(1):97-104.
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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