Belgian IBD research group (BIRD) position statement 2017 on the use of biosimilars in inflammatory bowel diseases (IBD)

Biosimilars are biological drugs which are similar to the authorized biologics ("reference product") but not identical (1). The European legislation has offered since 2006 a legal framework for biosimilars. The concept and methodology of the comparative investigations are further treated in the guidelines of the European Medicines Agency (EMA)(1). A biosimilar is only authorized when it can be stated with appropriate certainty that its variability and the differences with the reference medicinal product will not have a relevant influence on the safety or efficacy. EMA has approved a first one biosimilar to infliximab, namely CT-P13 and marketed with two brand names Remsima (2) and Inflectra (3), on the basis of two randomized controlled trials (RCT) in Rheumathoid Arthritis (RA) and Ankylosing Spondylitis (AS) (4, 5). More recently, a second biosimilar SB2, Flixabi (6), has been approved/registered and has also been evaluated in RA (7). According to EMA, the use of the biosimilar CT-P13 could be recommended in IBD from the extrapolation from the Planetra (5) and Planetas (4) studies in Rheumatologic diseases. Beyond the biosimilarity between the Infliximab reference product and the biosimilar CT-P13 and extrapolation of safety and efficacy in IBD, the cost-effectiveness of biosimilars is of great value as it dramatically reduces the burden of the cost of anti-TNFs to the health care system in Belgium. Initially, BIRD reserved its position on the broad use of biosimilars in IBD and has been waiting reassuring data on the following evidence : disease pathogeny and mode of action of infliximab are different within and between IBD and rheumatologic diseases.