Biosimilar biological drugs in the treatment of inflammatory bowel diseases

Abstract

Within the last 20 years, tumour necrosis factor inhibitors have been proven to be effective in achieving and maintaining clinical and endoscopic remission in patients with Crohn's disease and ulcerative colitis. Since 2013, when infliximab originator lost its patent protection, patients with inflammatory bowel diseases (IBDs) in Poland have also been treated with biosimilar drugs. Biosimilars are drugs with high similarity to their reference products in terms of physicochemical properties, including structure, safety, and efficacy. Biosimilars are approved for use on the basis of the same rigorous quality standards as their reference products. In 2018, also biosimilars of adalimumab have become available. Studies published to date have shown that biosimilars do not differ from reference drugs in terms of the efficacy and safety. There are numerous data to confirm that a single switch of biological drugs (mainly from reference to biosimilar drugs) has no effect on therapy efficacy and safety. However, a significantly lower cost of therapy with biosimilars not only allows us to treat a much larger number of patients but may also necessitate multiple switches from reference drugs to biosimilars (including biosimilars produced by different manufacturers). Recently, the first results have been published concerning multiple switches in patients with psoriasis and rheumatoid arthritis. However, no such data are currently available for patients with IBDs.

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

“…As in inflammatory arthritis, TNF-inhibitors have drastically changed the prognosis of inflammatory bowel diseases (IBDs), and BIOs have also become a reality in this peculiar category of patients. The only studies regarding the use of BIOs in paediatric age are focussed on IBDs and evaluated the efficacy, safety and immunogenicity of infliximab [32][33][34][35][36]47]. Alongside our data, they showed that switching from the reference drug to the BIO did not affect the efficacy of the drug and did not increase the rate of ADEs in a real-world setting [32][33][34][35][36]50].…”

“…The only studies regarding the use of BIOs in paediatric age are focussed on IBDs and evaluated the efficacy, safety and immunogenicity of infliximab [32][33][34][35][36]47]. Alongside our data, they showed that switching from the reference drug to the BIO did not affect the efficacy of the drug and did not increase the rate of ADEs in a real-world setting [32][33][34][35][36]50]. Even though we did not directly evaluate the efficacy and safety of infliximab in our study, and IBDs and JIA are different diseases, these results are consistent, supporting that biosimilars also show comparable properties to originators in paediatric age.…”

“…To date, large-scale paediatric trials are lacking, and only some observational studies in paediatric IBD are available for children [32][33][34][35][36]. In Italy, since 2018, ETA and ADA BIOs have been available for JIA as part of routine clinical practice.…”

Effect of tofacitinib on the phenotype and activity of Caco‑2 cells in a model of inflammatory bowel disease

“…The Caco-2 cell line (colon adenocarcinoma cell line) cultured under certain conditions may resemble enterocytes present in a normal intestine and previously have been used as a model system in research (1). The intestinal epithelium has the ability to function as a barrier between the external and internal environment.…”

“…The intestinal epithelium has the ability to function as a barrier between the external and internal environment. This ability is essential for human health, and disorders in this functioning due to increased intestinal permeability are associated with diseases such as: inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) or celiac disease (1). There are reports that tofacitinib may improve the functioning of the cellular barrier in the form of the intestinal epithelium in patients with enteritis (2).…”