The benefit of biosimilar monoclonal antibodies in the therapy of inflammatory bowel diseases

Czech version

Authors: Lukáš M.
Authors‘ workplace: Klinické a výzkumné centrum pro střevní záněty, Klinické centrum ISCARE a. s. a 1. LF UK v Praze
Published in: Gastroent Hepatol 2022; 76(5): 447-452
Category:
doi: https://doi.org/10.48095/ccgh2022447

Overview

Nineteen years ago, the biosimilars, “copies” of the original therapeutic monoclonal antibodies, have been introduced in the clinical practice. The beginnig was associated with some confusion from health care providers, but today it is indisputable that their implementation in practice was one of the most significant changes that led to an increase in the availability of biological treatment, cost reduction and significant impact on management of patients with inflammatory bowel diseases.

Keywords:

inflammatory bowel disease – biological treatment – biosimilars

Sources

1. Lukáš M. První generace biologických léčiv – anti-TNF monoklonální protilátky. In: Pokroky v diagnostice a léčbě idiopatických střevních zánětů. Praha: Galén 2019.

2. Jørgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with original infliximab (Nor-Switch): a randomized 52 week, double blind, non-inferiority study. Lancet 2017; 389 (10086): 2304–2316. doi: 10.1016/S0140-6736 (17) 30068-5.

3. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2022 [online]. Dostupné z: https: //www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged.

4. Kennedy NA, Heap GA, Green HD et al. Predictors of anti-TNF therapy failure in anti-TNF naive patinetrs with active luminal Crohn’s disease: a prospective, multicentre cohort study. Lancet Gastroenterol Hepatol 2019; 4 (5): 341–353. doi: 10.1016/S2468-1253 (19) 30012-3.

5. Reinisch W, Jang B, Borzan V et al. A novel formulation ofCT-P13 (infliximab biosimilar) for subcutaneous administration: 1 year results from a phase I open label randomized controlled trial in patients with active Crohn’s disease. J Crohns Colitis 2019; 13 (Suppl 1): S066–S067. doi: 10.1093/ecco-jcc/jjy222.096.

6. Lukáš M. Nové subkutánně podávané monoklonální protilátky. In: Idiopatické střevní záněty. Nové trendy amezioborové souvislosti. Praha: Grada Publishing 2020.

7. D’Amico F, Solitano V, Aletaha D et al. Biobetters in patients with immune-mediated inflammatory disorders: An international Delphi consensus. Autoimmun Rev 2021; 20 (7): 102849. doi: 10.1016/j.autrev.2021.102849.