{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T10:09:11Z","timestamp":1769076551987,"version":"3.49.0"},"reference-count":70,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2016,9,20]],"date-time":"2016-09-20T00:00:00Z","timestamp":1474329600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BioDrugs"],"published-print":{"date-parts":[[2016,10]]},"DOI":"10.1007\/s40259-016-0193-2","type":"journal-article","created":{"date-parts":[[2016,9,20]],"date-time":"2016-09-20T09:54:06Z","timestamp":1474365246000},"page":"469-480","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Infliximab Biosimilar (CT-P13; Infliximab-dyyb): A Review in Autoimmune Inflammatory Diseases"],"prefix":"10.1007","volume":"30","author":[{"given":"Hannah A.","family":"Blair","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma D.","family":"Deeks","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2016,9,20]]},"reference":[{"key":"193_CR1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-0348-0620-6_48-2","author":"KD Pile","year":"2016","unstructured":"Pile KD, Graham GG, Mahler SM. Disease-modifying anti-rheumatic drugs: overview. Compend Inflamm Dis. 2016. doi: 10.1007\/978-3-0348-0620-6_48-2 .","journal-title":"Compend Inflamm Dis."},{"issue":"1","key":"193_CR2","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1111\/joim.12432","volume":"279","author":"JD Isaacs","year":"2016","unstructured":"Isaacs JD, Cutolo M, Keystone EC, et al. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med. 2016;279(1):41\u201359.","journal-title":"J Intern Med."},{"issue":"3","key":"193_CR3","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1136\/annrheumdis-2013-204573","volume":"73","author":"JS Smolen","year":"2014","unstructured":"Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492\u2013509.","journal-title":"Ann Rheum Dis."},{"issue":"1","key":"193_CR4","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/acr.22783","volume":"68","author":"JA Singh","year":"2016","unstructured":"Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res. 2016;68(1):1\u201325.","journal-title":"Arthritis Care Res."},{"issue":"6","key":"193_CR5","doi-asserted-by":"crossref","first-page":"896","DOI":"10.1136\/ard.2011.151027","volume":"70","author":"J Braun","year":"2011","unstructured":"Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS\/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70(6):896\u2013904.","journal-title":"Ann Rheum Dis."},{"issue":"2","key":"193_CR6","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1002\/art.39298","volume":"68","author":"MM Ward","year":"2016","unstructured":"Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology\/Spondylitis Association of America\/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheum. 2016;68(2):282\u201398.","journal-title":"Arthritis Rheum."},{"issue":"3","key":"193_CR7","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1136\/annrheumdis-2015-208337","volume":"75","author":"L Gossec","year":"2016","unstructured":"Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75(3):499\u2013510.","journal-title":"Ann Rheum Dis."},{"issue":"12","key":"193_CR8","doi-asserted-by":"crossref","first-page":"2277","DOI":"10.1111\/jdv.13354","volume":"29","author":"A Nast","year":"2015","unstructured":"Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris-update 2015-short version-EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277\u201394.","journal-title":"J Eur Acad Dermatol Venereol."},{"issue":"5","key":"193_CR9","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1136\/gut.2010.224154","volume":"60","author":"C Mowat","year":"2011","unstructured":"Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60(5):571\u2013607.","journal-title":"Gut."},{"key":"193_CR10","unstructured":"European Crohn\u2019s and Colitis Organisation. ECCO e-guide algorithms. 2016. http:\/\/www.e-guide.ecco-ibd.eu . Accessed 6 Sep 2016."},{"key":"193_CR11","unstructured":"European Medicines Agency. Remsima: summary of product characteristics. 2013. http:\/\/www.ema.europa.eu . Accessed 6 Sep 2016."},{"key":"193_CR12","unstructured":"European Medicines Agency. Inflectra: summary of product characteristics. 2013. http:\/\/www.ema.europa.eu . Accessed 6 Sep 2016."},{"key":"193_CR13","unstructured":"Celltrion Inc. Inflectra (infliximab-dyyb) for injection, for intravenous use: US prescribing information. 2016. http:\/\/www.accessdata.fda.gov . Accessed 6 Sep 2016."},{"issue":"3","key":"193_CR14","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1007\/s40259-014-0094-1","volume":"28","author":"K McKeage","year":"2014","unstructured":"McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28(3):313\u201321.","journal-title":"BioDrugs."},{"key":"193_CR15","doi-asserted-by":"crossref","unstructured":"Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. mAbs. 2014;6(5):1163\u201377.","DOI":"10.4161\/mabs.32221"},{"key":"193_CR16","unstructured":"European Medicines Agency. Assessment report: Remsima (infliximab). 2013. http:\/\/www.ema.europa.eu . Accessed 6 Sep 2016."},{"key":"193_CR17","unstructured":"European Medicines Agency. Assessment report: Inflectra (infliximab). 2013. http:\/\/www.ema.europa.eu . Accessed 6 Sep 2016."},{"issue":"5","key":"193_CR18","doi-asserted-by":"crossref","first-page":"397","DOI":"10.2165\/00063030-199810050-00006","volume":"10","author":"SV Onrust","year":"1998","unstructured":"Onrust SV, Lamb HM. Infliximab: a review of its use in Crohn\u2019s disease and rheumatoid arthritis. BioDrugs. 1998;10(5):397\u2013422.","journal-title":"BioDrugs."},{"issue":"22","key":"193_CR19","doi-asserted-by":"crossref","first-page":"3191","DOI":"10.1182\/blood-2014-06-583617","volume":"124","author":"M Weise","year":"2014","unstructured":"Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191\u20136.","journal-title":"Blood."},{"issue":"9","key":"193_CR20","doi-asserted-by":"crossref","first-page":"1693","DOI":"10.1136\/annrheumdis-2015-208684","volume":"75","author":"MB Ruiz-Arguello","year":"2016","unstructured":"Ruiz-Arguello MB, Maguregui A, Ruiz Del Agua A, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016;75(9):1693\u20136.","journal-title":"Ann Rheum Dis."},{"issue":"6","key":"193_CR21","first-page":"1907","volume":"21","author":"S Ben-Horin","year":"2015","unstructured":"Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2015;21(6):1907\u201314.","journal-title":"Gut."},{"issue":"10","key":"193_CR22","doi-asserted-by":"crossref","first-page":"1605","DOI":"10.1136\/annrheumdis-2012-203091","volume":"72","author":"W Park","year":"2013","unstructured":"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(10):1605\u201312.","journal-title":"Ann Rheum Dis."},{"issue":"6","key":"193_CR23","doi-asserted-by":"crossref","first-page":"817","DOI":"10.3109\/14397595.2015.1022297","volume":"25","author":"T Takeuchi","year":"2015","unstructured":"Takeuchi T, Yamanaka H, Tanaka Y, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25(6):817\u201324.","journal-title":"Mod Rheumatol."},{"issue":"Suppl 1","key":"193_CR24","doi-asserted-by":"crossref","first-page":"S25","DOI":"10.1586\/1744666X.2015.1090311","volume":"11","author":"W Park","year":"2015","unstructured":"Park W, Lee SJ, Yun J, et al. Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, phase I study. Expert Rev Clin Immunol. 2015;11(Suppl 1):S25\u201331.","journal-title":"Expert Rev Clin Immunol."},{"issue":"12","key":"193_CR25","doi-asserted-by":"crossref","first-page":"2247","DOI":"10.1097\/MIB.0000000000000212","volume":"20","author":"I Dotan","year":"2014","unstructured":"Dotan I, Ron Y, Yanai H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel Dis. 2014;20(12):2247\u201359.","journal-title":"Inflamm Bowel Dis."},{"issue":"10","key":"193_CR26","doi-asserted-by":"crossref","first-page":"1613","DOI":"10.1136\/annrheumdis-2012-203090","volume":"72","author":"DH Yoo","year":"2013","unstructured":"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(10):1613\u201320.","journal-title":"Ann Rheum Dis."},{"key":"193_CR27","unstructured":"Nippon Kayaku. A randomized, double-blind, phase I\/II study of CT-P13 compared with Remicade in patients with rheumatoid arthritis. 2013. http:\/\/www.clinicaltrials.jp . Accessed 6 Sep 2016."},{"key":"193_CR28","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1186\/s13075-016-0981-6","volume":"18","author":"DH Yoo","year":"2016","unstructured":"Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82.","journal-title":"Arthritis Res Ther."},{"key":"193_CR29","unstructured":"Sung Y-K, Cho S-K, Won S, et al. Characteristics and outcomes of RA patients who start biosimilar infliximab in South Korea [abstract no. 1221]. Arthritis Rheum. 2015;67(Suppl S10):1558\u20139."},{"key":"193_CR30","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1186\/s13075-016-0930-4","volume":"18","author":"W Park","year":"2016","unstructured":"Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25.","journal-title":"Arthritis Res Ther."},{"issue":"2","key":"193_CR31","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1093\/ecco-jcc\/jjv220","volume":"10","author":"KB Gecse","year":"2016","unstructured":"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(2):133\u201340.","journal-title":"J Crohns Colitis."},{"issue":"Suppl 1","key":"193_CR32","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1586\/17474124.2015.1091308","volume":"9","author":"J Jahnsen","year":"2015","unstructured":"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 1):45\u201352.","journal-title":"Expert Rev Gastroenterol Hepatol."},{"key":"193_CR33","doi-asserted-by":"crossref","unstructured":"Zagorowicz E, Kierkus J, Klopocka M, et al. Comparison of infliximab the originator and biosimilars in treatment of Crohn\u2019s disease: a Polish cohort study [abstract no. P513]. J Crohns Colitis. 2016;10 (Suppl 1):S360\u20131.","DOI":"10.1093\/ecco-jcc\/jjw019.632"},{"key":"193_CR34","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjw085","author":"K Farkas","year":"2016","unstructured":"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. doi: 10.1093\/ecco-jcc\/jjw085 .","journal-title":"J Crohns Colitis."},{"issue":"12","key":"193_CR35","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.1111\/jgh.12997","volume":"30","author":"YS Jung","year":"2015","unstructured":"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(12):1705\u201312.","journal-title":"J Gastroenterol Hepatol."},{"key":"193_CR36","doi-asserted-by":"crossref","unstructured":"Kaniewska M, Rydzewska G. Efficacy and safety of biosimilar of infliximab (Inflectra) in adult patients with Crohn\u2019s disease during 1 year of treatment, followed 6 months of observation: a one-centre retrospective study [abstract no. P519]. J Crohns Colitis. 2016;10(Suppl 1):S363.","DOI":"10.1093\/ecco-jcc\/jjw019.638"},{"key":"193_CR37","doi-asserted-by":"crossref","unstructured":"Kaniewska M, Rydzewska G. Efficacy and safety of biosimilar of infliximab in rescue therapy in adult patients with severe ulcerative colitis [abstract no. P645]. J Crohns Colitis. 2016;10(Suppl 1):S428.","DOI":"10.1016\/S0016-5085(16)31712-7"},{"key":"193_CR38","doi-asserted-by":"crossref","unstructured":"Carvalho Lourenco L, Anapaz V, Oliveira AM, et al. Biosimilar infliximab in real-life Crohn\u2019s disease\u2019s anti-TNFalfa naive patients: a comparative observational cohort study (SIMRECRO study) [abstract no. P327]. J Crohns Colitis. 2016;10(Suppl 1):S259.","DOI":"10.1093\/ecco-jcc\/jjw019.446"},{"key":"193_CR39","doi-asserted-by":"crossref","unstructured":"Bortlik M, Kolar M, Duricova D, et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naive to anti-TNF therapy: a tertiary centre experience [abstract no. P495]. J Crohns Colitis. 2016;10(Suppl 1):S351.","DOI":"10.1016\/S0016-5085(16)30461-9"},{"issue":"Suppl 1","key":"193_CR40","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1586\/17474124.2015.1091309","volume":"9","author":"SH Park","year":"2015","unstructured":"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\u201344.","journal-title":"Expert Rev Gastroenterol Hepatol."},{"key":"193_CR41","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208783","author":"W Park","year":"2016","unstructured":"Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2016. doi: 10.1136\/annrheumdis-2015-208783 .","journal-title":"Ann Rheum Dis."},{"key":"193_CR42","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208786","author":"DH Yoo","year":"2016","unstructured":"Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2016. doi: 10.1136\/annrheumdis-2015-208786 .","journal-title":"Ann Rheum Dis."},{"key":"193_CR43","doi-asserted-by":"crossref","unstructured":"Glintborg B, Sorensen IJ, Vendelbo Jensen D, et al. Three months\u2019 clinical outcomes from a nationwide non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis. Results from the DANBIO registry [abstract no. OP0225]. In: EULAR Annual Meeting. 2016.","DOI":"10.1136\/annrheumdis-2016-eular.1785"},{"key":"193_CR44","doi-asserted-by":"crossref","unstructured":"Fiorino G, Manetti N, Variola A, et al. Prospective observational study on IBD patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort [abstract no. P544 plus poster]. J Crohns Colitis. 2016;10(Suppl 1):S376-7.","DOI":"10.1093\/ecco-jcc\/jjw019.663"},{"key":"193_CR45","doi-asserted-by":"crossref","unstructured":"Diaz Hernandez L, Rodriguez Gonzalez GE, Vela Gonzalez M, et al. Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months [abstract no. P449]. J Crohns Colitis. 2016;10(Suppl 1):S327.","DOI":"10.1093\/ecco-jcc\/jjw019.568"},{"key":"193_CR46","doi-asserted-by":"crossref","unstructured":"Guerra Veloz MF, Arguelles Arias F, Perea Amarillo R, et al. Safety and efficacy of infliximab biosimilar (Remsima\u00a9) in Crohn\u2019s disease patients in clinical practice: results after 6 months of treatment [abstract no. P452]. J Crohns Colitis. 2016;10(Suppl 1):S328\u20139.","DOI":"10.1093\/ecco-jcc\/jjw019.571"},{"key":"193_CR47","doi-asserted-by":"crossref","unstructured":"Kolar M, Duricova D, Brotlik M, et al. Switching of patients with inflammatory bowel disease from original infliximab (Remicade\u00ae) to biosimilar infliximab (Remsima\u2122) is effective and safe [abstract no. DOP032]. J Crohns Colitis. 2016;10(Suppl 1):S45\u20136.","DOI":"10.1016\/S0016-5085(16)31445-7"},{"key":"193_CR48","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjw087","author":"L Smits","year":"2016","unstructured":"Smits L, Derikx L, de Jong DJ, et al. Clinical outcomes following a switch from Remicade\u00ae 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 .","journal-title":"J Crohns Colitis."},{"issue":"2","key":"193_CR49","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1093\/ecco-jcc\/jjv233","volume":"10","author":"J Sieczkowska","year":"2016","unstructured":"Sieczkowska J, Jarzebicka 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\u201332.","journal-title":"J Crohns Colitis."},{"key":"193_CR50","doi-asserted-by":"crossref","unstructured":"Guerra Veloz MF, Arguelles Arias F, Perea Amarillo R, et al. Safety and efficacy of infliximab biosimilar (Remsima\u00a9) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment [abstract no. P600]. J Crohns Colitis. 2016;10(Suppl 1):S405.","DOI":"10.1093\/ecco-jcc\/jjw019.719"},{"key":"193_CR51","doi-asserted-by":"crossref","unstructured":"Bennett KJ, Heap GA, Hawkins S, et al. Prospective evaluation of the safety and efficacy of switching stable patients with inflammatory bowel disease from Remicade\u2122 to biosimilar infliximab (IFX) [abstract no. PWE-017]. In: BSG Congress. 2016.","DOI":"10.1136\/gutjnl-2016-312388.263"},{"key":"193_CR52","doi-asserted-by":"crossref","unstructured":"Rahmany S, Cotton S, Garnish S, et al. In patients with IBD switching from originator infliximab (Remicade) to biosimilar infliximab (CT-P13) is safe and effective [abstract no. PTU-073]. In: BSG Congress. 2016.","DOI":"10.1136\/gutjnl-2016-312388.158"},{"key":"193_CR53","doi-asserted-by":"crossref","unstructured":"Sieczkowska J, Jarzebicka D, Oracz G, et al. Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn\u2019s disease [abstract no. P617]. J Crohns Colitis. 2016;10(Suppl 1):S413\u20134.","DOI":"10.1093\/ecco-jcc\/jjw019.736"},{"issue":"Suppl 1","key":"193_CR54","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1586\/17474124.2015.1091306","volume":"9","author":"W Reinisch","year":"2015","unstructured":"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. 2015;9(Suppl 1):17\u201326.","journal-title":"Expert Rev Gastroenterol Hepatol."},{"key":"193_CR55","unstructured":"American College of Rheumatology. American College of Rheumatology position statement: biosimilars. 2016. http:\/\/www.rheumatology.org . Accessed 6 Sep 2016."},{"key":"193_CR56","doi-asserted-by":"crossref","unstructured":"Danese S, Gomollon F, on behalf of the 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;7:586\u20139.","DOI":"10.1016\/j.crohns.2013.03.011"},{"issue":"1","key":"193_CR57","first-page":"60","volume":"39","author":"JE Fonseca","year":"2014","unstructured":"Fonseca JE, Goncalves J, Araujo F, et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol Port. 2014;39(1):60\u201371.","journal-title":"Acta Reumatol Port."},{"issue":"5","key":"193_CR58","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1016\/j.reuma.2015.03.009","volume":"11","author":"MA Abad Hernandez","year":"2015","unstructured":"Abad Hernandez MA, Andreu JL, Caracuel Ruiz MA, et al. Position paper from the Spanish Society of Rheumatology on biosimilar drugs. Reumatol Clin. 2015;11(5):269\u201378.","journal-title":"Reumatol Clin."},{"key":"193_CR59","unstructured":"National Institute for Health and Care Excellence. Biosimilar medicines. 2016. https:\/\/www.nice.org.uk . Accessed 6 Sep 2016."},{"issue":"12","key":"193_CR60","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1038\/nbt.2438","volume":"30","author":"HC Ebbers","year":"2012","unstructured":"Ebbers HC, Crow SA, Vulto AG, et al. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol. 2012;30(12):1186\u201390.","journal-title":"Nat Biotechnol."},{"key":"193_CR61","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products. 2014. http:\/\/www.ema.europa.eu . Accessed 6 Sep 2016."},{"key":"193_CR62","unstructured":"British Society for Rheumatology. British Society for Rheumatology position statement on biosimilar medicines. 2015. http:\/\/www.rheumatology.org.uk . Accessed 6 Sep 2016."},{"issue":"4","key":"193_CR63","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/j.biologicals.2016.03.006","volume":"44","author":"J Braun","year":"2016","unstructured":"Braun J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44(4):257\u201366.","journal-title":"Biologicals."},{"key":"193_CR64","unstructured":"The Center for Biosimilars. Will we see big biosimilar savings by 2020? Two drugs may tell the story. 2016. http:\/\/www.centerforbiosimilars.com . Accessed 6 Sep 2016."},{"issue":"2","key":"193_CR65","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1007\/s00296-014-3080-5","volume":"35","author":"VF Azevedo","year":"2015","unstructured":"Azevedo VF, Galli N, Kleinfelder A, et al. Etanercept biosimilars. Rheumatol Int. 2015;35(2):197\u2013209.","journal-title":"Rheumatol Int."},{"issue":"Suppl 1","key":"193_CR66","doi-asserted-by":"crossref","first-page":"S65","DOI":"10.1007\/s10198-014-0595-3","volume":"15","author":"V Brodszky","year":"2014","unstructured":"Brodszky V, Baji P, Balogh O, et al. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six central and eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65\u201371.","journal-title":"Eur J Health Econ."},{"issue":"Suppl 10","key":"193_CR67","first-page":"S512","volume":"66","author":"J Kim","year":"2014","unstructured":"Kim J, Hong JA, Kudrin A. 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany [abstract no. 1166]. Arthritis Rheum. 2014;66(Suppl 10):S512.","journal-title":"Arthritis Rheum."},{"key":"193_CR68","doi-asserted-by":"crossref","unstructured":"Kim J, Hong JA, Kudrin A, et al. 5\u00a0year budget impact analysis of CT-P13 (infliximab) for the treatment of Crohn\u2019s disease in UK, Italy and\u00a0France [abstract no. P137]. J Crohns Colitis. 2015;9 (Suppl 1):S144\u20135.","DOI":"10.1093\/ecco-jcc\/jju027.254"},{"issue":"1","key":"193_CR69","first-page":"119","volume":"16","author":"V Brodszky","year":"2016","unstructured":"Brodszky V, Rencz F, Pentek M, et al. A budget impact model for biosimilar infliximab in Crohn\u2019s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia. Expert Rev Pharmacoecon Outcomes Res. 2016;16(1):119\u201325.","journal-title":"Expert Rev Pharmacoecon Outcomes Res."},{"issue":"8","key":"193_CR70","doi-asserted-by":"crossref","first-page":"742","DOI":"10.1007\/s12325-015-0233-1","volume":"32","author":"A Jha","year":"2015","unstructured":"Jha A, Upton A, Dunlop WC, et al. The budget impact of biosimilar infliximab (Remsima\u00ae) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32(8):742\u201356.","journal-title":"Adv Ther."}],"container-title":["BioDrugs"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40259-016-0193-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40259-016-0193-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40259-016-0193-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T20:14:10Z","timestamp":1749586450000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40259-016-0193-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,9,20]]},"references-count":70,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,10]]}},"alternative-id":["193"],"URL":"https:\/\/doi.org\/10.1007\/s40259-016-0193-2","relation":{},"ISSN":["1173-8804","1179-190X"],"issn-type":[{"value":"1173-8804","type":"print"},{"value":"1179-190X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,9,20]]}}}