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a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2022; 76(1): 42–45. doi: 10.48095/ccgh202242.

Biosimilar treatment in paediatric gastroenterology – current view

Jiří Bronský  1

+ Affiliation


Biosimilar drugs (BSD) have been used in the field of gastroenterology since 2013, when the European Medicines Agency approved biosimilar infliximab for the treatment of inflammatory bowel disease (IBD). The view of these drugs has changed significantly in the course of their use. At first, BSDs were used with hesitation, mainly due to the lack of published data on their efficacy and safety and also due to the lack of clinical experience. Over the following years, a number of studies were published that gradually support their importance in the treatment of IBD, and BSDs are now routinely administered to patients naïve to biological treatment, and a number of centres perform switches from the original treatment to a BSD. In paediatrics, a more reserved attitude towards their clinical use persisted for a long time, but with the growing amount of published data, they are also common in clinical practice. This summary article describes the development in the approach of both international and domestic professional societies and physicians-clinicians to the use of BSL and provides references to newly published studies of biosimilar drugs.


pediatrie, biosimilární léčiva, biologic therapy, evropská léková agentura, switch, extrapolace

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1. Biosimilars 2021 Year in Review [online]. Available from: https: // 2021-year-in-review/.
2. de Ridder L, Waterman M, Turner D et al. Use of biosimilars in paediatric inflammatory bowel disease: a position statement of the ESPGHAN paediatric IBD porto group. J Pediatr Gastroenterol Nutr 2015; 61(4): 503–508. doi: 10.1097/MPG.0000000000000903.
3. de Ridder L, Assa A, Bronsky J et al. Use of biosimilars in pediatric inflammatory bowel disease: an updated position statement of the pediatric IBD porto group of ESPGHAN. J Pediatr Gastroenterol Nutr 2019; 68(1): 144–153. doi: 10.1097/MPG.0000000000002141.
4. Danese S, Gomollon F. Governing board and operational board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 2013; 7(7): 586–589. doi: 10.1016/j.crohns.2013.03.011.
5. Danese S, Fiorino G, Raine T et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease – an update. J Crohns Colitis 2017; 11(1): 26–34. doi: 10.1093/ecco-jcc/jjw198.
6. Bortlík M, Ďuricová D, Kohout P et al. Doporučení pro podávání biologické léčby pacientům s idiopatickými střevními záněty: třetí, aktualizované vydání. Gastroent Hepatol 2016; 70(1): 11–27. doi: 10.14735/amgh201611.
7. Bortlík M, Ďuricová D, Douda T et al. Doporučení pro podávání biologické léčby pacientům s idiopatickými střevními záněty: čtvrté, aktualizované vydání. Gastroent Hepatol 2019; 73(1): 11–24. doi: 10.14735/amgh201911.
8. Bronský J, Beránková K, Černá Z et al. Doporučení Pracovní skupiny dětské gastroenterologie a výživy ČPS pro diagnostiku a léčbu nespecifických střevních zánětů u dětí – doplněk k 1. vydání. Gastroent Hepatol 2017; 71(1): 11–18. doi: 10.14735/amgh201711.
9. Haifer C, Srinivasan A, An YK et al. Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study. Med J Aust 2021; 214(3): 128–133. doi: 10.5694/mja2.50824.
10. Martínez-Feito A, Bravo-Gallego LY, Hernández-Breijo B et al. Infliximab concentrations in two non-switching cohorts of patients with inflammatory bowel disease: originator vs. biosimilar. Sci Rep 2020; 10(1): 17099. doi: 10.1038/s41598-020-74235-1.
11. Nikkonen A, Kolho KL. Infliximab and its biosimilar produced similar first-year therapy outcomes in patients with inflammatory bowel disease. Acta Paediatr 2020; 109(4): 836–841. doi: 10.1111/apa.15026.
12. Kamat N, Kedia S, Ghoshal UC et al. Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: a multicenter study. Indian J Gastroenterol 2019; 38(1): 44–54. doi: 10.1007/s12664-018-0922-1.
13. van Hoeve K, Dreesen E, Hoffman I et al. Efficacy, pharmacokinetics, and immunogenicity is not affected by switching from infliximab originator to a biosimilar in pediatric patients with inflammatory bowel disease. Ther Drug Monit 2019; 41(3): 317–324. doi: 10.1097/FTD.0000000000000601.
14. Bálint A, Rutka M, Kolar M et al. Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis – results from multicenter observational cohort. Expert Opin Biol Ther 2018; 18(11): 1181–1187. doi: 10.1080/14712598.2018.1530758.
15. Armuzzi A, Fiorino G, Variola A et al. The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the effectiveness and safety across Italy. Inflamm Bowel Dis 2019; 25(3): 568–579. doi: 10.1093/ibd/izy264.
16. Gervais L, McLean LL, Wilson ML et al. Switching from originator to biosimilar infliximab in paediatric inflammatory bowel disease is feasible and uneventful. J Pediatr Gastroenterol Nutr 2018; 67(6): 745–748. doi: 10.1097/MPG.0000000000002091.
17. Smits LJT, van Esch AAJ, Derikx LAAP et al. Drug survival and immunogenicity after switching from remicade to biosimilar CT-P13 in inflammatory bowel disease patients: two-year follow-up of a prospective observational cohort study. Inflamm Bowel Dis 2019; 25(1): 172–179. doi: 10.1093/ibd/izy227.
18. Høivik ML, Buer LCT, Cvancarova M et al. Switching from originator to biosimilar infliximab – real world data of a prospective 18 months follow-up of a single-centre IBD population. Scand J Gastroenterol 2018; 53(6): 692–699. doi: 10.1080/00365521.2018.1463391.
19. Chanchlani N, Mortier K, Williams LJ et al. Use of infliximab biosimilar versus originator in a pediatric United Kingdom inflammatory bowel disease induction cohort. J Pediatr Gastroenterol Nutr 2018; 67(4): 513–519. doi: 10.1097/MPG.0000000000002011.
20. Binkhorst L, Sobels A, Stuyt R et al. Short article: switching to a infliximab biosimilar: short-term results of clinical monitoring in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2018; 30(7): 699–703. doi: 10.1097/MEG.0000000000001113.
21. Kang B, Lee Y, Lee K et al. Long-term outcomes after switching to CT-P13 in pediatric-onset inflammatory bowel disease: a single-center prospective observational study. Inflamm Bowel Dis 2018; 24(3): 607–616. doi: 10.1093/ibd/izx047.
22. Farkas K, Rutka M, Ferenci T et al. Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn‘s disease and ulcerative colitis – experiences from a single center. Expert Opin Biol Ther 2017; 17(11): 1325–1332. doi: 10.1080/14712598.2017.1363885.
23. Smits LJT, Grelack A, Derikx LAAP et al. Long-term clinical outcomes after switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease. Dig Dis Sci 2017; 62(11): 3117–3122. doi: 10.1007/s10620-017-4661-4.
24. Reinisch W, Jahnsen J, Schreiber S et al. Evaluation of the cross-reactivity of antidrug antibodies to CT-P13 and infliximab reference product (Remicade): an analysis using immunoassays tagged with both agents. BioDrugs 2017; 31(3): 223–237. doi: 10.1007/s40259-017-0219-4.
25. Jahnsen J, Kaasen Jørgensen K. Experience with biosimilar infliximab (Remsima®) in Norway. Dig Dis 2017; 35(1–2): 83–90. doi: 10.1159/000449088.
26. Razanskaite V, Bettey M, Downey L et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme. J Crohns Colitis 2017; 11(6): 690–696. doi: 10.1093/ecco-jcc/jjw216.
27. Fiorino G, Manetti N, Armuzzi A et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis 2017; 23(2): 233–243. doi: 10.1097/MIB.0000000000000995.
28. Buer LC, Moum BA, Cvancarova M et al. Switching from Remicade® to Remsima® is well tolerated and feasible: a prospective, open-label study. J Crohns Colitis 2017; 11(3): 297–304. doi: 10.1093/ecco-jcc/jjw166.
29. Farkas K, Rutka M, Golovics PA et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis 2016; 10(11): 1273–1278. doi: 10.1093/ecco-jcc/jjw085.
30. Smits LJ, Derikx LA, de Jong DJ et al. Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohns Colitis 2016; 10(11): 1287–1293. doi: 10.1093/ecco-jcc/jjw087.
31. Keil R, Wasserbauer M, Zádorová Z et al. Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn‘s disease and ulcerative colitis. Scand J Gastroenterol 2016; 51(9): 1062–1068. doi: 10.3109/00365521.2016.1149883.
32. Sieczkowska J, Jarzębicka D, Banaszkiewicz A et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis 2016; 10(2): 127–132. doi: 10.1093/ecco-jcc/jjv233.
33. Park SH, Kim YH, Lee JH et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; 9(Suppl 1): 35–44. doi: 10.1586/17474124.2015.1091309.
34. Schreiber S, Ben-Horin S, Leszczyszyn J et al. Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory bowel disease. Gastroenterology 2021; 160(7): 2340–2353. doi: 10.1053/j.gastro.2021.02.068.
35. Jongsma MME, Aardoom MA, Cozijnsen MA et al. First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn‘s disease: an open-label multicentre randomised controlled trial. Gut 2022; 71(1): 34–42. doi: 10.1136/gutjnl-2020-322339.
36. Dipasquale V, Romano C. Biosimilar infliximab in paediatric inflammatory bowel disease: efficacy, immunogenicity and safety. J Clin Pharm Ther 2020; 45(6): 1228–1234. doi: 10.1111/jcpt.13239.
37. FDA-TRACK: Center for Drug Evaluation & Research – Pre-Approval Safety Review – Biosimilars Dashboard. 2021 [online]. Available from: https: //
38. Bronsky J, de Ridder L, Ruemmele FM et al. Diagnostic and therapeutic approach in paediatric inflammatory bowel diseases: results from a clinical practice survey. J Pediatr Gastroenterol Nutr 2019; 68(5): 676–683. doi: 10.1097/MPG.0000000000002233.
39. Dipasquale V, Martinelli M, Aloi M et al. Real-life use of biosimilars in pediatric inflammatory bowel disease: a nation-wide web survey on behalf of the SIGENP IBD working group. Paediatr Drugs 2022; 24(1): 57–62. doi: 10.1007/s40272-021-00486-8.

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