The European Medicines Agency (EMA) approved its first monoclonal antibody (mAb) biosimilar infliximab (Inflectra, Remsima) in July 2013 for the same indications as the originator product Remicade [1]. The indications cover a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. These indications go beyond those studied for the biosimilar [2].

These approvals have prompted the Polish Society of Gastroenterology to initiate a study to evaluate the safety of anti-tumour necrosis factor (TNF) antibodies, including biosimilars, in the treatment of IBD over a two-year period. Data on response, tolerability and safety of anti-TNF and on concomitant treatment will be collected.

The trial is a prospective, multicentre, observational cohort study. The main objective of the study is to assess the safety of treatment with anti-TNF monoclonal antibodies in IBD patients in Poland. The primary outcome of the trial is the frequency of adverse events on induction of remission and maintenance treatment using anti-TNFs (including biosimilars) in a cohort of IBD patients over a period of up to three years. The trial will include 400 paediatric and adult patients, in whom anti-TNF treatment is started for Crohn’s disease, ulcerative colitis or indeterminate colitis, financed by the National Health Care System.

The trial will include the majority of IBD centres in Poland, including paediatric and adult, academic and regional. It is expected to last two years and is expected to be completed in December 2016.

References
1. Thorpe R, Wadhwa M. Biosimilar monoclonal antibodies approved for use in the EU. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):9. doi:10.5639/gabij.2014.0301.004
2. ECCO survey highlights lack of confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):154. doi:10.5639/gabij.2014.0303.034

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