Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects

Drugs

Volumn 76, Issue 15, 2016, Pages 1413-1420

  Gecse, Krisztina B ^a   Lakatos, Péter L ^a  

^a SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; CT-P13;

ANKYLOSING SPONDYLITIS; ARTICLE; CLINICAL TRIAL (TOPIC); COMFORT; EUROPEAN MEDICINES AGENCY; FUTUROLOGY; HUMAN; INFLAMMATORY BOWEL DISEASE; MULTICENTER STUDY (TOPIC); NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; TREATMENT INDICATION; ARTHRITIS, RHEUMATOID; INFLAMMATORY BOWEL DISEASES; SPONDYLITIS, ANKYLOSING;

ANTIBODIES, MONOCLONAL; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; INFLAMMATORY BOWEL DISEASES; INFLIXIMAB; SPONDYLITIS, ANKYLOSING;

EID: 84987660547     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-016-0638-4     Document Type: Article

References (43)

1. D’Haens GR, Panaccione R, Higgins PD, Vermeire S, Gassull M, Chowers Y, et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn’s and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol. 2011;106(2):199–212 (quiz 3).
2. European Medicines Agency. Biosimilar medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp. Accessed 8 June 2016.
3. Declerck PJ. Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert Opin Biol Ther. 2013;13(2):153–6.
4. McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs. 2011;3(2):209–17.
5. Guideline on similar biological medicinal products [Internet]. 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf. Accessed 7 Sep 2016.
6. Similar biological medicinal products containing monoclonal antibodies—non-clinical and clinical issues [Internet]. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed 7 Sep 2016.
7. Mellstedt H. Clinical considerations for biosimilar antibodies. EJC Suppl. 2013;11(3):1–11.
8. Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385–8.
9. European Medicines Agency. Assessment report: Inflectra. London: EMA; 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf. Accessed 31 Aug 2016.
10. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, 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(10):1613–20.
11. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, 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(10):1605–12.
12. 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):586–9.
13. Arguelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. 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(1):37–43.
14. Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I, 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(7):751–5.
15. Felson DT, LaValley MP. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Res Ther. 2014;16(1):101.
16. Vande Casteele N, Khanna R, Levesque BG, Stitt L, Zou GY, Singh S, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut. 2015;64(10):1539–45.
17. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41(9):1552–63.
18. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367–74.
19. Levin AD, Wildenberg ME, van den Brink GR. Mechanism of action of anti-TNF therapy in inflammatory bowel disease. J Crohns Colitis. 2016;10:989–97.
20. Sandborn WJ, Hanauer SB, Katz S, Safdi M, Wolf DG, Baerg RD, et al. Etanercept for active Crohn’s disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2001;121(5):1088–94.
21. Kang YS, Moon HH, Lee SE, Lim YJ, Kang HW. 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(4):951–6.
22. Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, 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(12):1705–12.
23. Jahnsen J, Detlie TE, Vatn S, Ricanek P. Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl 1):45–52.
24. Gecse KB, Lovasz BD, Farkas K, Banai J, Bene L, Gasztonyi B, 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(2):133–40.
25. Farkas K, Rutka M, Golovics PA, Vegh Z, Lovasz BD, Nyari T, et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis. 2016. doi:10.1093/ecco-jcc/jjw085.
26. Hamanaka S, Nakagawa T, Koseki H, Sakurai T, Taida T, Okimoto K, Saito K, Maruoka D, Matsumura T, Katsuno T, Arai M, Yokosuka O. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study. J Crohns Colitis. 2016;10(Suppl 1):P329.
27. Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12(11):1473–85.
28. Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10(2):127–32.
29. Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, 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. doi:10.1093/ecco-jcc/jjw087.
30. Guerra Veloz MF, Argüelles Arias F, Perea Amarillo R, Castro Laria L, Maldonado Pérez MB, Benítez Roldán A, Merino V, Ramirez G, Vilches Arenas A, Caunedo Álvarez A. Safety and efficacy of infliximab biosimilar (Remsima©) in Crohn’s disease patients in clinical practice: results after 6 months of treatment. J Crohns Colitis. 2016;10(Suppl 1):P452.
31. Guerra Veloz MF, Argüelles Arias F, Perea Amarill R, Castro Laria L, Maldonado Pérez MB, Benítez Roldán A, Merino V, Ramirez G, Vilches Arenas A, Caunedo Álvarez A. Safety and efficacy of infliximab biosimilar (Remsima©) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. J Crohns Colitis. 2016;10(Suppl 1):P600.
32. Díaz Hernández L, Rodríguez González GE, Vela González M, Tardillo Marín CA, Rodríguez Díaz CY, Arranz Hernández L, Montero Delgado JA, San Juan Acosta M, Pérez Hernández F. Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months. J Crohns Colitis. 2016;10(Suppl 1):P449.
33. Bettey M, Downey L, Underhill C, Callaghan J, Rush M, Ahmed I, Cummings F. Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab. J Crohns Colitis. 2016;10(Suppl 1):DOP029.
34. ®) to biosimilar infliximab (Remsima™) is effective and safe. J Crohns Colitis. 2016;10(Suppl 1):DOP032.
35. Fiorino G, Manetti N, Variola A, Bossa F, Rizzuto G, Guidi L, Maconi G, Ghione S, Cantoro L, Lorenzon G, Fries W, Annunziata ML, Costa F, Terpin MM, Principi B, Cortelezzi C, Biancone L, Amato A, Occhipinti P, Mazzuoli S, Ardizzone S, Di Girolamo M, Alvisi P, Meucci G, Caserta L, Saibeni S, Petruzzellis C, Ronchetti A, Cappello M, Castiglione F, Danese S, Massella A, Varvara D, Orlando A, Armuzzi A, Massari A, Lionetti P, Kohn A, D’Incà R, Vecchi M, Bertani L, Annese V, on behalf of IG-IBD. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD. J Crohns Colitis. 2016;10(Suppl 1):P544.
36. ClinicalTrials.gov. Efficacy and safety of infliximab-biosimilar (Inflectra) compared to infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR trial. Available from: https://clinicaltrials.gov/ct2/show/study/NCT02452151?term=infliximab+and+biosimilar&rank=1. Accessed 31 Aug 2016.
37. Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis. 2013;72(10):1589–93.
38. Koelewijn C, Schrijvers A, Oldenburg B. Infliximab use in patients with Crohn’s disease: quality of life, costs and resource use. Neth J Med. 2006;64(7):212–8.
39. Brodszky V, Rencz F, Pentek M, Baji P, Lakatos PL, Gulacsi L. A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia. Expert Rev Pharmacoecon Outcomes Res. 2016;16(1):119–25.
40. Danese S, Fiorino G, Michetti P. Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey amongst ECCO members. J Crohns Colitis. 2016;10(Suppl 1):P312.
41. Ben-Horin S, Yavzori M, Benhar I, Fudim E, Picard O, Ungar B, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65(7):1132–8.
42. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431–5.
43. Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use May 2016. 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/05/WC500206416.pdf. Accessed 31 Aug 2016.