Biosimilars in inflammatory bowel disease.

The introduction of biologic therapies has revolutionized the treatment of inflammatory bowel disease (IBD) and has significantly improved the disease course and outcomes for many patients. Biologics are the main drivers of cost in many IBD units and biosimilars, although are not better than originators, are usually cheaper and thus can increase the availability of this type of therapy. Biosimilar are highly similar to innovator but, due to the complex structures of innovators and the variability inherent in the manufacturing process, they are no identical. This fact cause concerns with respect to the efficacy and safety in medical community, especially in the medical indications in which no specific clinical trials with biosimilars have been performed as IBD. Nowadays, two biosimilars to infliximab, CT-P13 and SB2, has been approved by European Medicines Agency in all the indications of the reference product. To date, the available evidence suggests that switch from reference medicinal product (infliximab) to the biosimilar (CT-P13 or SB2) is feasible since published studies have not observed significantly difference in terms of efficacy, immunogenicity and safety. However, the experts agreed that by now there is not sufficient evidence to consider infliximab biosimilars interchangeable with the originator compound. In this manuscript, we will review the processes involved in the manufacturing and regulatory approval of biosimilars and examine the evidence presently available on approved biosimilars in Europe for IBD.