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Review

Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)

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HoUng Kim, Rieke Alten, Fraser Cummings, Silvio Danese, Geert D’Haens, Paul Emery, Subrata Ghosh, Cyrielle Gilletta de Saint Joseph, JongHyuk Lee, James O. Lindsay, Elena Nikiphorou, Ben Parker, Stefan Schreiber, Steven Simoens, Rene Westhovens, Ji Hoon Jeong & Laurent Peyrin-Biroulet. (2021) Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters. mAbs 13:1.
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Dae Hyun Yoo, Jung-Yoon Choe, Seung Cheol Shim & Chang-Hee Suh. (2018) Switching to biosimilars in the treatment of rheumatic diseases. Expert Review of Clinical Immunology 14:7, pages 557-571.
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Dae Hyun Yoo. (2017) CT-P13 in the treatment of rheumatoid arthritis. Expert Review of Clinical Immunology 13:7, pages 653-666.
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J. Braun & J. Kay. (2017) The safety of emerging biosimilar drugs for the treatment of rheumatoid arthritis. Expert Opinion on Drug Safety 16:3, pages 289-302.
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Abdoulie Jallow, Huali Xie, Xiaoqian Tang, Zhang Qi & Peiwu Li. (2021) Worldwide aflatoxin contamination of agricultural products and foods: From occurrence to control. Comprehensive Reviews in Food Science and Food Safety 20:3, pages 2332-2381.
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Robert J. Flanagan, Eva Cuypers, Hans H. Maurer & Robin Whelpton. 2020. Fundamentals of Analytical Toxicology. Fundamentals of Analytical Toxicology 145 166 .
Gregor Jordan & Roland F Staack. (2020) Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody–reagent complexes at cut-point (CP-ARC) the missing piece?. Bioanalysis 12:14, pages 1021-1031.
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Johanna R Mora, Joleen T White, Shannon D Chilewski, Qiang Qu, Dennis Stocker, Linlin Luo & Amy Lavelle. (2020) Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program. Bioanalysis 12:7, pages 431-443.
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HoUng Kim, Rieke Alten, Luisa Avedano, Axel Dignass, Fernando Gomollón, Kay Greveson, Jonas Halfvarson, Peter M. Irving, Jørgen Jahnsen, Péter L. Lakatos, JongHyuk Lee, Souzi Makri, Ben Parker, Laurent Peyrin-Biroulet, Stefan Schreiber, Steven Simoens, Rene Westhovens, Silvio Danese & Ji Hoon Jeong. (2020) The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases. Drugs 80:2, pages 99-113.
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Vibeke Strand, Joao Gonçalves, Timothy P. Hickling, Heather E. Jones, Lisa Marshall & John D. Isaacs. (2019) Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents. BioDrugs 34:1, pages 27-37.
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Gloria S. Z. Tun, Robert Downey, Kerry Robinson, Alison Wright, Laura Marshall, Kristina Emsell, Kirsty Swallow, Graeme Wild, Alenka J. Brooks, Thean S. Chew, Melissa F. Hale, Ravishankar Sargur & Alan J. Lobo. (2019) High prevalence of antibodies to infliximab and their relation to clinical outcomes in inflammatory bowel disease patients. GastroHep 1:5, pages 214-222.
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Vladimir V. KlimovVladimir V. Klimov. 2019. From Basic to Clinical Immunology. From Basic to Clinical Immunology 217 235 .
Lieke Tweehuysen, Victor J. B. Huiskes, Bart J. F van den Bemt, Johanna E. Vriezekolk, Steven Teerenstra, Frank H. J. van den Hoogen, Cornelia H. van den Ende & Alfons A. den Broeder. (2018) Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4. Arthritis & Rheumatology 70:9, pages 1408-1418.
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Wenfang S. Wu, Liang Zhu, Saurabh Patil, Karthiga Gokul, Sean Reilly, Joyce Chan, Poornima Tekumalla, Vivek Vishnudas, Michael A. Kiebish, Rangaprasad Sarangarajan, Viatcheslav R. Akmaev, Mark D. Kellogg & Niven R. Narain. (2018) Human CCDC47 sandwich immunoassay development with electrochemiluminescence technology. Journal of Immunological Methods 452, pages 12-19.
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Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini & Meenu Wadhwa. (2018) Reprint of “Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab”. Cytokine 101, pages 70-77.
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Paul Chamberlain & Pekka Kurki. 2018. Biosimilars. Biosimilars 489 542 .
Dae Hyun Yoo. (2017) Comparative effectiveness of the biosimilar CT-P13. Journal of Comparative Effectiveness Research 6:8, pages 693-712.
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Niels Vande Casteele. (2017) Assays for measurement of TNF antagonists in practice. Frontline Gastroenterology 8:4, pages 236-242.
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Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini & Meenu Wadhwa. (2017) Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab. Cytokine 96, pages 16-23.
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Walter Reinisch, Jørgen Jahnsen, Stefan Schreiber, Silvio Danese, Julián Panés, Alejandro Balsa, Won Park, JiSoo Kim, Jee Un Lee & Dae Hyun Yoo. (2017) 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 31:3, pages 223-237.
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Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Slawomir Jeka, Francisco Fidencio Cons-Molina, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Francisco G Medina-Rodriguez, Pavel Shesternya, Sebastiao Radominski, Marina Stanislav, Volodymyr Kovalenko, Dong Hyuk Sheen, Leysan Myasoutova, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Taek Sang Kwon & Won Park. (2017) A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Annals of the Rheumatic Diseases 76:3, pages 566-570.
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Christina Y. Ha & Asher Kornbluth. (2016) A Critical Review of Biosimilars in IBD. Inflammatory Bowel Diseases 22:10, pages 2513-2526.
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Eszter Lázár-Molnár & Julio C Delgado. (2016) Immunogenicity Assessment of Tumor Necrosis Factor Antagonists in the Clinical Laboratory. Clinical Chemistry 62:9, pages 1186-1198.
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