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a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2021; 75(6): 550–555. doi: 10.48095/ccgh2021550.

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?

Milan Lukáš1

+ Affiliation


In 2013, EMA approved the first biosimilar infliximab CT-P13 for clinical practice in all indications of the original infliximab. Since 2015, biosimilar infliximab has been extensively used in patients with Crohn‘s disease and ulcerative colitis also in the Czech Republic. Biosimilar infliximab is very similar to the original infliximab in terms of its macromolecular structure, and its clinical effects, adverse events and immunogenicity are identical to those of the original infliximab. Biosimilar biologics which have been introduced in clinical practice significantly reduced therapeutic costs and improved access to an innovative therapy and facilitated a new therapeutic strategy, with pro-active drug monitoring and flexibility in dosing. Biosimilars are associated with a significant improvement in the therapeutic armamentarium, which makes them one of the important therapeutic milestones in the treatment of inflammatory bowel disease.


biologic therapy, ulcerózní kolitida, Crohn’s disease, bio­similární léčiva

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1. Lukáš M et al. Pokroky v dia­gnostice a léčbě idiopatických střevních zánětů. Praha: Galen 2019.
2. Jorgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to bio­similat CT-P13 compared with maintained treatment with original infliximab (NOR-SWITCH): a randomised 52 week, randomised, double-blide, non-inferiority study. Lancet 2017; 389(10086): 2304-2316. doi: http: // S0140-6736(17)30068-5.
3. Kennedy NA, Heap GA, Green HD et al. Predictors of anti-TNF therapy failure in anti-TNF. Lancet 2019; 4(5): 341-353. doi: http: //
4. Lukáš M. Biologická léčba idiopatických střevních zánětů. In: Pavelka K, Arenberger P, Lukáš M et al (eds). Biologická léčba zánětlivých autoimunitních onemocnění v revmatologii, dermatologii a gastroenterologii. Praha: Grada 2014.
5. Lukáš M et al. Idiopatické střevní záněty. Nové trendy a mezioborové souvislosti. Praha: Grada 2020.
6. Ahmed W, Galati J, Kumar et al. Dual bio­logic or small molecule therapy for treatment of inflammatory bowel disease: A systematic review and meta-analysis. Clin Gastro Hepatol 2021. In press. doi: https: //

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