Biosimilars monoclonal antibodies in the therapy of inflammatory bowel diseases An important milestone in the development of Crohn’s disease and ulcerative colitis therapy, or just a sophisticated generic?

Summary: In 2013, EMA approved the fi rst biosimilar infl iximab CT-P13 for clinical practice in all indications of the original infl iximab. Since 2015, biosimilar infl iximab has been extensively used in patients with Crohn‘s disease and ulcerative colitis also in the Czech Republic. Biosimilar infl iximab is very similar to the original infl iximab in terms of its macromolecular structure, and its clinical eff ects, adverse events and immunogenicity are identical to those of the original infl iximab. Biosimilar biologics which have been introduced in clinical practice signifi cantly reduced therapeutic costs and improved access to an innovative therapy and facilitated a new therapeutic strategy, with pro-active drug monitoring and fl exibility in dosing. Biosimilars are associated with a signifi cant improvement in the therapeutic armamentarium, which makes them one of the important therapeutic milestones in the treatment of infl ammatory bowel disease. Key words: bio similars – bio logic therapy – Crohn’s disease – ulcerative colitis