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Current Medicinal Chemistry

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ISSN (Print): 0929-8673
ISSN (Online): 1875-533X

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Review Article

Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review

Author(s): Laura Martelli and Laurent Peyrin-Biroulet*

Volume 26, Issue 2, 2019

Page: [270 - 279] Pages: 10

DOI: 10.2174/0929867323666161014153346

Price: $65

Abstract

Background: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD.

Methods: A PubMed literature search was performed using the following terms until May 2016: ‘biosimilars’, ‘CT-P13’, ‘infliximab’, ‘Crohn’s disease’, ‘ulcerative colitis’, ‘inflammatory bowel diseases’, ‘efficacy’, ‘safety’, ‘immunogenicity’. Additionally, abstracts from international meetings were also reviewed.

Results: A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on the available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator.

Conclusion: The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

Keywords: Biosimilar, CT-P13, infliximab, inflammatory bowel disease, efficacy, safety, immunogenicity.

« Previous Next »
[1]
Park, D.I. Current status of biosimilars in the treatment of inflammatory bowel diseases. Intest. Res., 2016, 14(1), 15-20.
[2]
Jahnsen, J. Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients. Therap. Adv. Gastroenterol., 2016, 9(3), 322-329.
[3]
Rinaudo-Gaujous, M.; Paul, S.; Tedesco, E.D.; Genin, C.; Roblin, X.; Peyrin-Biroulet, L. Review article: Biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment. Pharmacol. Ther., 2013, 38(8), 914-924.
[4]
Amiot, A.; Peyrin-Biroulet, L. Current, new and future biological agents on the horizon for the treatment of inflammatory bowel diseases. Therap. Adv. Gastroenterol., 2015, 8(2), 66-82.
[5]
Park, W.; Hrycaj, P.; Jeka, S.; Kovalenko, V.; Lysenko, G.; Miranda, P.; Mikazane, H.; Gutierrez-Ureña, S.; Lim, M.; Lee, Y.A.; Lee, S.J.; Kim, H.; Yoo, D.H.; Braun, J. 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), 1605-1612.
[6]
Yoo, D.H.; Hrycaj, P.; Miranda, P.; Ramiterre, E.; Piotrowski, M.; Shevchuk, S.; Kovalenko, V.; Prodanovic, N.; Abello-Banfi, M.; Gutierrez-Ureña, S.; Morales-Olazabal, L.; Tee, M.; Jimenez, R.; Zamani, O.; Lee, S.J.; Kim, H.; Park, W.; Müller-Ladner, U. 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), 1613-1620.
[7]
Reinisch, W.; Louis, E.; Danese, S. The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13. Expert Rev. Gastroenterol. Hepatol., 9(Suppl. 1), 17-26.
[8]
Jung, Y.S.; Park, D.I.; Kim, Y.H.; Lee, J.H.; Seo, P.J.; Cheon, J.H.; Kang, H.W.; Kim, J.W. 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), 1705-1712.
[9]
Park, S.H.; Kim, Y.H.; Lee, J.H.; Kwon, H.J.; Lee, S.H.; Park, D.I.; Kim, H.K.; Cheon, J.H.; Im, J.P.; Kim, Y.S.; Lee, S.Y.; Lee, S.J. 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.
[10]
Keil, R.; Wasserbauer, M.; Zadorova, Z.; Hajer, J.; Drastich, P.; Wohl, P.; Beneš, M.; Bojková, M. Svoboda, P4.; Konečný, M.; Falt, P6.; Vaňásek, T.; Pešta, M.; Pešek, F.; Bouchner, L.; Koželuhová, J.; Novotný, A.; Bartůsková, L.; Špičák, J. Clinical monitoring: Infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis. Scand. J. Gastroenterol., 2016, 51(9), 1062-1068.
[11]
Gecse, K.B.; Lovász, B.D.; Farkas, K.; Banai, J.; Bene, L.; Gasztonyi, B.; Golovics, P.A.; Kristóf, T.; Lakatos, L.; Csontos, Á.A.; Juhász, M.; Nagy, F.; Palatka, K.; Papp, M.; Patai, Á.; Lakner, L.; Salamon, Á.; Szamosi, T.; Szepes, Z.; Tóth, G.T.; Vincze, Á.; Szalay, B.; Molnár, T.; Lakatos, P.L. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: A prospective, multicentre, nationwide cohort. J. Crohn’s Colitis, 2016, 10(2), 133-140.
[12]
Jahnsen, J.; Detlie, T.E.; 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.
[13]
Smits, L.J.; Derikx, L.A.; de Jong, D.J.; Boshuizen, R.S.; van Esch, A.A.; Drenth, J.P.; Hoentjen, F. Clinical outcomes following a switch from Remicade to the biosimilar CT-P13 in inflammatory bowel disease patients: A prospective observational cohort study. J. Crohn’s Colitis, 2016, 10(11), 1287-1293.
[14]
Bortlik, M.; Kolar, M.; Duricova, D.; Malickova, K.; Hruba, V.; Machkova, N.; Mitrova, K.; Lukas, M.; Lukas, M. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to anti-TNF therapy: A tertiary centre experience. ECCO 2016. Poster Presentations: Clinical: Therapy & Observation,, 2016. p. 495.
[15]
Kolar, M.; Duricová, D.; Brotlik, M.; Duricova, D.; Brotlik, M.; Hruba, V.; Machkova, N.; Milrova, K.; Malickova, K.; Lukas, M. DOP032. Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe. ECCO 2016. Abstract 2016. DOP Session 4 - IFX & IFX biosimilars 2016.
[16]
Fiorino, G.; Manetti, N.; Variola, A.; Fabrizio, B. Giulia, Rizzuto.; Alessandro, Armuzzi.; Alessandro, Massari.; Silvia, Ghione.; Laura, Cantoro.; Greta, Lorenzon.; Walter, F.; Maria, L.A.; Francesco, C.; Maria. M.T.; Mariabeatrice P.; Cortelezzi, C.C.; Biancone, L.; Amato, A.; Occhipinti, P.; Mazzuoli, S.; Ardizzone, S.; Girolamo, M.D.; Alvisi, P.; Meucci, G.; Caserta, L.; Saibeni, S.; Petruzzzellis, C.; Ronchetti, A.; Cappello, M.; Castiglione, F.; Danese, S.; Massella, A.; Varvara, D.; Orlando, A.; Annese, V. The PROSIT-BIO Cohort of the IG-IBD: A prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilars. Gastroenterology,, 2016. 150(4), (Suppl. 1), S92.
[17]
Papamichael, K.; Van Stappen, T.; Jairath, V.; Gecse, K.; Khanna, R. DHaens, G.; Vermeire, S.; Gils, A.; Feagan, B.G.; Levesque, B.G.; Vande Casteele, N. Review article: Pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Aliment. Pharmacol. Ther., 2015, 42(10), 1158-1169.
[18]
Ben-Horin, S.; Yavzori, M.; Benhar, I.; Fudim, E.; Picard, O.; Ungar, B.; Lee, S.; Kim, S.; Eliakim, R.; Chowers, Y. Cross-immunogenicity: Antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut, 2015, 65(7), 1132-1138.
[19]
Malickova, K.; Duricova, D.; Kolar, M.; Bortlik, M.; Hruba, V.; Machkova, N.; Mitrova, K.; Lukas, M.; Lukas, M. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: Short-term results. ECCO 2016. Poster presentations: Clinical: Therapy & observation,, 2016. 150(4), Suppl.416, P311.
[20]
ClinicalTrials.gov. The NOR-SWITCH Study. Available at: https://clinicaltrials.gov/ct2/show/results/NCT02148640
[21]
ClinicalTrials.gov. Demonstrate non-inferiority in efficacy and to assess safety of CT-P13 in patients with active crohn's disease. Available at: Https://clinicaltrials.gov/ ct2/show/NCT02096861
[22]
Danese, S.; Fiorino, G.; Michetti, P. Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey amongst ECCO members. ECCO 2016. Poster presentations: Clinical: Therapy & observation,, 2016. p. 312.
[23]
Peyrin-Biroulet, L.; Lönnfors, S.; Danese, S.; Roblin, X.; Avedano, L.; Greco, M. Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn’s and Ulcerative Colitis Associations;, ECCO,. 2016, p.432.

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