Biosimilars in der Behandlung chronisch entzündlicher Darmerkrankungen^[*]

Zusammenfassung

Nach Ablauf des Patentschutzes für Infliximab 2013 wurde unmittelbar das Biosimilar CT‑P13 für die Therapie des Morbus Crohn und der Colitis ulcerosa bei Erwachsenen und Kindern zugelassen. Die Zulassung beruht auf dem Nachweis des Biosimilars in den Indikationen rheumatoide Arthritis und ankylosierende Spondylitis, bei denen die Äquivalenz in Bezug auf Pharmakokinetik, Wirkung und Nebenwirkungen im Rahmen randomisierter Studien nachgewiesen wurde. Die bisherigen klinischen Erfahrungen und mehrere nicht randomisierte Studien zeigen eine klinische Wirksamkeit und vergleichbare Immunogenität des Infliximab-Biosimilars CT-P13 bei chronisch entzündlichen Darmerkrankungen. Ein Einsatz von Biosimilars in der Primärtherapie erscheint daher gerechtfertigt. Ein enges Monitoring der Sicherheit von Biosimilars in Bezug auf die Effektivität und auf Nebenwirkungen muss auch in der Zukunft gewährleistet sein.

Abstract

After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT‑P13 was approved for indications in Crohn’s disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience since, in addition to multiple non-randomized studies, indicate a comparable efficacy and immunogenicity of the Infliximab biosimilar CT-P13 in inflammatory bowel disease. Thus, the introduction of the biosimilar as primary therapy seems to be justified. Tight monitoring of the safety of biosimilars with regard to efficacy and side effects has to be ensured.

Schlüsselwörter

chronisch entzündliche Darmerkrankung - Biosimilar - Infliximab

Key words

inflammatory bowel disease - biosimilar - Infliximab

^* Bei diesem Beitrag handelt es sich um ein Positionspapier des „Kompetenznetz Darmerkrankungen“.

• Literatur

• 1 Billiet T, Rutgeerts P, Ferrante M et al. Targeting TNF-alpha for the treatment of inflammatory bowel disease. Expert Opin Biol Ther 2014; 14: 75-101
• 2 Willrich MA, Murray DL, Snyder MR. Tumor necrosis factor inhibitors: clinical utility in autoimmune diseases. Transl Res 2015; 165: 270-282
• 3 McCamish M, Woollett G. The rise of the biosimilar. Expert Rev Clin Pharmacol 2012; 5: 597-599
• 4 Schiestl M, Stangler T, Torella C et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29: 310-312
• 5 Schiestl M. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products. Biologicals 2011; 39: 297-299
• 6 Park W, Hrycaj P, Jeka S et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605-1612
• 7 Yoo DH, Hrycaj P, Miranda P et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72: 1613-1620
• 8 Annese V, Vecchi M. Italian Group for the Study of IBD. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease. Dig Liver Dis 2014; 46: 963-968
• 9 Arguelles-Arias F, Barreiro-de-Acosta M, Carballo F et al. Joint position statement by "Sociedad Espanola de Patologia Digestiva" (Spanish Society of Gastroenterology) and "Sociedad Espanola de Farmacologia" (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013; 105: 37-43
• 10 Danese S, Gomollon F, Governing B et al. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 2013; 7: 586-589
• 11 Devlin SM, Bressler B, Bernstein CN et al. Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol 2013; 27: 567-571
• 12 Feagan BG, Choquette D, Ghosh S et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014; 42: 177-183
• 13 Fiorino G, Girolomoni G, Lapadula G et al. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev 2014; 13: 751-755
• 14 Schreiber S, Luger T, Mittendorf T et al. Evolution of biologicals in inflammation medicine – biosimilars in gastroenterology, rheumatology and dermatology. Dtsch Med Wochenschr 2014; 139: 2399-2404
• 15 Danese S, Fiorino G, Michetti P. Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization. J Crohns Colitis 2014; 8: 1548-1550
• 16 Danese S, Fiorino G, Michetti P. Changes in biosimilar knowledge among European Crohn's Colitis Organization (ECCO) members: A updated survey. J Crohns Colitis 2016;
• 17 Peyrin-Biroulet L, Lönnfors S, Danese S et al. P432: Patient perspectives on biosimilars: a European Federation of Crohn's and Colitis Association survey. J Crohns Colitis 2016; 10/S1: 318
• 18 Gecse KB, Lovasz BD, Farkas K et al. Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort. J Crohns Colitis 2016; 10: 133-140
• 19 Gecse KB, Vegh Z, Kurti Z et al. DOP028: Efficacy and safety of biosimilar infliximab after one year: results from a nationwide cohort. J Crohns Colitis 2016; 10: 133-140
• 20 Bortlik M, Kolar M, Duricova D et al. P495: Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naive to anti-TNF therapy: a tertiary centre experience. J Crohns Colitis 2016; 10/S1: 351
• 21 Jahnsen J, Detlie TE, Vatn S et al. Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study. Expert Rev Gastroenterol Hepatol 2015; 9 (Suppl. 01) 45-52
• 22 Jung YS, Park DI, Kim YH et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol 2015; 30: 1705-1712
• 23 Fiorino G, Manetti N, Variola A et al. The PROSIT-BIO of the IG-IBD: A prospective observational study of patients with inflammatory bowel disease treated with Infliximab biosimilars. Gastroenterology 2016; 150: A439
• 24 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;
• 25 Golovics PA, Vegh Z, Rutka M et al. OP003: Predicting short and medium-term efficacy of the biosimilar infliximab: trough levels/do anti-drug antibody's or clinical/biochemical markers play a more important role?. J Crohns Colitis 2016; 10/S1: 2
• 26 Balint A, Farkas K, Rutka M et al. DOP010: Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from a Central European nationwide cohort. J Crohns Colitis 2016; 10/S1: 31
• 27 Smits LJ, Derikx LA, de Jong DJ et al. Clinical outcomes following a switch from Remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohns Colitis 2016;
• 28 Kolar M, Duricova D, Brotlik M et al. DOP032: Switching of patients with inflammatory bowel diseases from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe. J Crohns Colitis 2016; 10/S1: S45
• 29 Kolar M, Duricova D, Bortlik M et al. Switching of patients with inflammatory bowel disease from original Infliximab (Remicade®) to biosimilar Infliximab (Remsima^TM) is effective and safe. Gastroenterology 2016; 150: Sa1957
• 30 Choe JY, Prodanovic N, Niebrzydowski J et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2015;
• 31 Kang YS, Moon HH, Lee SE et al. Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series. Dig Dis Sci 2015; 60: 951-956
• 32 Gecse KB, Vegh Z, Kurti Z et al. Efficacy and safety of biosimilar infliximab after one-year: results from a prospective nationwide cohort. Gastroenterology 2016; 150: Sa1936
• 33 Jarzebicka D, Banaszkiewicz A, Plocek A et al. Preliminary assessment of efficacy and safet of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Crohns Colitis 2015; 9: 224-225