Abstract
Biosimilars in Gastroenterology- An Important Moment in the Treatment of Inflammatory Bowel Diseases
Highlights
In Europe, the patent of infliximab expired and the EMA has already approved a biosimilar of this medication on the European market
Our own centre’s retrospective study concerning the efficacy and safety of a biosimilar of infliximab (Inflectra), in a cohort of 176 adult patients with Crohn’s disease (CD) over one year of treatment followed by 6 months of observation, suggested similar results in efficacy and safety to a counterpart infliximab and adalimumab, in induction and one year CD therapy, and during the 6-month follow-up [12]
Further retrospective data concerning the efficacy and safety of a biosimilar of infliximab in rescue therapy in the cases of 67 adult patients with severe ulcerative colitis (UC), suggested similar results in efficacy and safety compared to a counterpart infliximab, both in the rescue therapy of UC and during the 6-month follow-up [13]
Summary
In Europe, the patent of infliximab expired and the EMA has already approved a biosimilar of this medication on the European market. Mostly retrospective data evaluating efficacy and safety of biosimilars in IBD have been published [7,8,9]. The first prospective randomized clinical trials were recently published, but they are still limited [10, 11].
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