Volume 81 - 2018 - Fasc.1 - Position statements
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.
The Belgian Association for Study of the Liver Guidance Document on the Management of Adult and Paediatric Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver Disease (NAFLD) is highly prevalent and associated with considerable liver-related and non-liver- related morbidity and mortality. There is, however, a lot of uncertainty on how to handle NAFLD in clinical practice. The current guidance document, compiled under the aegis of the Belgian Association for the Study of the Liver by a panel of experts in NAFLD, from a broad range of different specialties, covers many questions encountered in daily clinical practice regarding diagnosis, screening, therapy and follow-up in adult and paediatric patients. Guidance statements in this document are based on the available evidence whenever possible. In case of absence of evidence or inconsistency of the data, guidance statements were formulated based on consensus of the expert panel. This guidance document is intended as a help for clinicians (general practitioners and all involved specialties) to implement the most recent evidence and insights in the field of NAFLD within a Belgian perspective. (Acta gastroenterol. belg., 2018, 81, 55-81).