{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T11:33:04Z","timestamp":1786793584253,"version":"build-2736575974"},"reference-count":119,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T00:00:00Z","timestamp":1496275200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Curr Rheumatol Rep"],"published-print":{"date-parts":[[2017,6]]},"DOI":"10.1007\/s11926-017-0658-4","type":"journal-article","created":{"date-parts":[[2017,6,16]],"date-time":"2017-06-16T07:55:02Z","timestamp":1497599702000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":86,"title":["Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician"],"prefix":"10.1007","volume":"19","author":[{"given":"Robert","family":"Moots","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valderilio","family":"Azevedo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier L.","family":"Coindreau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"D\u00f6rner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ehab","family":"Mahgoub","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Mysler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morton","family":"Scheinberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Marshall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2017,6,16]]},"reference":[{"key":"658_CR1","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products. 2014. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/10\/WC500176768.pdf . Accessed 31 Mar 2016."},{"key":"658_CR2","unstructured":"United States Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/UCM291128.pdf . Accessed 31 Mar 2016."},{"key":"658_CR3","unstructured":"World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2010. http:\/\/www.who.int\/biologicals\/areas\/biological_therapeutics\/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 31 Mar 2016."},{"key":"658_CR4","doi-asserted-by":"crossref","unstructured":"Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology\u2013\u201cO Brave New World\u201d. Nat Rev Rheumatol. 2012;8:430\u20136.","DOI":"10.1038\/nrrheum.2012.84"},{"key":"658_CR5","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1007\/s00296-016-3444-0","volume":"36","author":"E Mysler","year":"2016","unstructured":"Mysler E, Pineda C, Horiuchi T, Singh E, Mahgoub E, Coindreau J, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36:613\u201325. doi: 10.1007\/s00296-016-3444-0 .","journal-title":"Rheumatol Int"},{"key":"658_CR6","unstructured":"United States Food and Drug Administration. Guidance for industry on biosimilars: Q & As regarding implementation of the BPCI Act of 2009: Questions and answers part I. 2016. http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm259809.htm . Accessed 07 Oct 2016."},{"key":"658_CR7","unstructured":"United States Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry (draft guidance). 2017. https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM537135.pdf . Accessed 28 Feb 2017."},{"key":"658_CR8","doi-asserted-by":"publisher","first-page":"713","DOI":"10.1038\/nrrheum.2015.110","volume":"11","author":"T Dorner","year":"2015","unstructured":"Dorner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2015;11:713\u201324. doi: 10.1038\/nrrheum.2015.110 .","journal-title":"Nat Rev Rheumatol"},{"key":"658_CR9","doi-asserted-by":"publisher","first-page":"88","DOI":"10.5639\/gabij.2014.0302.022","volume":"3","author":"HC Ebbers","year":"2014","unstructured":"Ebbers HC, Chamberlain P. Interchangeability. An insurmountable fifth hurdle? GaBI J. 2014;3:88\u201393. doi: 10.5639\/gabij.2014.0302.022 .","journal-title":"GaBI J"},{"key":"658_CR10","doi-asserted-by":"publisher","first-page":"434","DOI":"10.1002\/sim.5569","volume":"32","author":"L Endrenyi","year":"2013","unstructured":"Endrenyi L, Chang C, Chow SC, Tothfalusi L. On the interchangeability of biologic drug products. Stat Med. 2013;32:434\u201341. doi: 10.1002\/sim.5569 .","journal-title":"Stat Med"},{"key":"658_CR11","doi-asserted-by":"publisher","first-page":"S2","DOI":"10.1016\/j.semarthrit.2015.04.002","volume":"44","author":"R Alten","year":"2015","unstructured":"Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:S2\u20138. doi: 10.1016\/j.semarthrit.2015.04.002 .","journal-title":"Semin Arthritis Rheum"},{"key":"658_CR12","doi-asserted-by":"publisher","unstructured":"Dorner T, Strand V, Cornes P, Goncalves J, Gulacsi L, Kay J, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis. 2016;75:974\u201382. doi: 10.1136\/annrheumdis-2016-209166 .","DOI":"10.1136\/annrheumdis-2016-209166"},{"key":"658_CR13","doi-asserted-by":"crossref","unstructured":"Faccin F, Tebbey P, Alexander E, Wang X, Cui L, Albuquerque T. The design of clinical trials to support the switching and alternation of biosimilars. Expert Opin Biol Ther. 2016;16:1445\u201353.","DOI":"10.1080\/14712598.2017.1238454"},{"key":"658_CR14","unstructured":"European Medicines Agency. European public assessment reports (biosimilars). http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit . Accessed 31 Oct 2016."},{"key":"658_CR15","unstructured":"United States Food and Drug Administration. Center for drug evaluation and research list of licensed biological products. 2016. http:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/UCM439049.pdf . Accessed 31 Oct 2016."},{"key":"658_CR16","unstructured":"Samsung Bioepis. Samsung Bioepis\u2019 biologics license application for SB2 infliximab biosimilar accepted by FDA. 2016. http:\/\/www.businesswire.com\/news\/home\/20160523006086\/en\/Samsung-Bioepis-Biologics-License-Application-SB2-Infliximab . Accessed 31 Oct 2016."},{"key":"658_CR17","unstructured":"Novartis. Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept. 2015. https:\/\/www.novartis.com\/news\/media-releases\/sandoz-advances-its-biosimilars-program-european-medicines-agency-ema-acceptance . Accessed 31 Oct 2016."},{"key":"658_CR18","unstructured":"Globe Newswire. Coherus BioSciences regains development and commercial rights to CHS-0214 from Shire. 2016. https:\/\/globenewswire.com\/news-release\/2016\/09\/27\/874893\/0\/en\/Coherus-BioSciences-Regains-Development-and-Commercial-Rights-to-CHS-0214-From-Shire.html . Accessed 31 Oct 2016."},{"key":"658_CR19","unstructured":"European Medicines Agency. Human medicines: pending EC decisions: Amgevita. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/004212\/smops\/Positive\/human_smop_001091.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human . Accessed 28 Feb 2017."},{"key":"658_CR20","unstructured":"European Medicines Agency. Human medicines: pending EC decisions: Solymbic. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/004373\/smops\/Positive\/human_smop_001092.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human . Accessed 28 Feb 2017."},{"key":"658_CR21","unstructured":"Biogen. SB5, an adalimumab biosimilar referencing Humira\u00ae, accepted for review by European Medicines Agency. 2016. http:\/\/media.biogen.com\/press-release\/biosimilars\/sb5-adalimumab-biosimilar-referencing-humira-accepted-review-european-medi . Accessed 31 Oct 2016."},{"key":"658_CR22","doi-asserted-by":"publisher","unstructured":"Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA. 2015. http:\/\/www.gabionline.net\/Biosimilars\/News\/Celltrion-submits-rituximab-biosimilar-application-to-EMA . Accessed 31 Oct 2016. doi: 10.3402\/ijch.v74.27284 .","DOI":"10.3402\/ijch.v74.27284"},{"key":"658_CR23","unstructured":"Novartis. New data demonstrates Sandoz\u2019 etanercept and rituximab biosimilar candidates bioequivalent to originator products. 2016. https:\/\/www.novartis.com\/news\/media-releases\/new-data-demonstrates-sandoz-etanercept-and-rituximab-biosimilar-candidates . Accessed 31 Oct 2016."},{"key":"658_CR24","unstructured":"Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. American College of Rheumatology 2013; San Diego, California, USA: 2013."},{"key":"658_CR25","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1136\/annrheumdis-2015-208786","volume":"76","author":"DH Yoo","year":"2017","unstructured":"\u2022 Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, 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. 2017;76:355\u201363. doi: 10.1136\/annrheumdis-2015-208786 . This study is the largest study of switching from infliximab to CT-P13 exclusively in patients with rheumatoid arthritis, and specifically compares clinical data before and after switching.","journal-title":"Ann Rheum Dis"},{"key":"658_CR26","unstructured":"Park W, Miranda P, Brzosko M, Wiland P, Gutierrez-Ure\u00f1a S, Mikazane H, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. American College of Rheumatology 2013; San Diego, California, USA: 2013."},{"key":"658_CR27","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1136\/annrheumdis-2015-208783","volume":"76","author":"W Park","year":"2017","unstructured":"\u2022 Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ure\u00f1a S, 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. 2017;76:346\u201354. doi: 10.1136\/annrheumdis-2015-208783 . This study is the largest study of switching from infliximab to CT-P13 exclusively in patients with ankylosing spondylitis, and specifically compares clinical data before and after switching.","journal-title":"Ann Rheum Dis"},{"key":"658_CR28","doi-asserted-by":"crossref","unstructured":"Tanaka Y, Yamanaka H, Takeuchi T, Inoue M, Saito K, Saeki Y, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2017;27:237-45.","DOI":"10.1080\/14397595.2016.1206244"},{"key":"658_CR29","doi-asserted-by":"crossref","unstructured":"Yazici Y, Xie L, Ogbomo A, Parenti D, Goyal K, Teeple A, et al. A descriptive analysis of real-world treatment patterns in a Turkish rheumatology population that continued innovator infliximab (Remicade) therapy or switched to biosimilar infliximab. American College of Rheumatology; 2016 Washington DC, USA: Arthritis Rheumatol. 2016;68 (suppl10). http:\/\/acrabstracts.org\/abstract\/a-descriptive-analysis-of-real-world-treatment-patterns-in-a-turkish-rheumatology-population-that-continued-innovator-infliximab-remicade-therapy-or-switched-to-biosimilar-infliximab\/ Accessed 17 May 2017.","DOI":"10.1136\/annrheumdis-2017-eular.1128"},{"key":"658_CR30","volume-title":"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","author":"B Glintborg","year":"2016","unstructured":"\u2022 Glintborg B, S\u00f8rensen IJ, Jensen DV, Krogh NS, Loft AG, Colic A, 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. Scandinavian Congress of Rheumatology; Reykjavik: 2016. The DANBIO registry analysis is the largest real-world study of the effects of switching from infliximab to CT-P13 in patients with rheumatic disease to date. This publication provides important early clinical data on the efficacy of switching."},{"key":"658_CR31","doi-asserted-by":"crossref","unstructured":"\u2022 Glintborg B, Kringelbach T, H\u00f8gdall E, S\u00f8rensen IJ, Jensen DV, Loft AG, et al. Non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis: impact on s-infliximab and antidrug antibodies. Results from the Danish Rheumatological Biobank and the DANBIO registry. Scandinavian Congress of Rheumatology; Reykjavik: 2016. The DANBIO registry analysis is the largest real-world study of the effects of switching from infliximab to CT-P13 in patients with rheumatic disease to date. This publication provides important early immunogenicity data on the effect of switching.","DOI":"10.1136\/annrheumdis-2016-eular.1477"},{"key":"658_CR32","doi-asserted-by":"crossref","unstructured":"\u2022 Glintborg B, Kringelbach T, H\u00f8gdall E, S\u00f8rensen IJ, Jensen DV, Loft AG, et al. Non-medical switch from originator to biosimilar infliximab among patients with inflammatory rheumatic disease\u2013impact on s-infliximab and anti-drug antibodies. Results from the National Danish Rheumatologic Biobank and the DANBIO registry. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. The DANBIO registry analysis is the largest real-world study of the effects of switching from infliximab to CT-P13 in patients with rheumatic disease to date. This publication provides important early immunogenicity data on the effects of switching.","DOI":"10.1136\/annrheumdis-2016-eular.1477"},{"key":"658_CR33","doi-asserted-by":"crossref","unstructured":"\u2022 Glintborg B, S\u00f8rensen IJ, Jensen DV, Krogh NS, Loft AG, Espesen J, et al. A nationwide non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis. Eleven months\u2019 clinical outcomes from the Danbio Registry. American College of Rheumatology 2016; Washington DC, USA: 2016. The DANBIO registry analysis is the largest real-world study of the effects of switching from infliximab to CT-P13 in patients with rheumatic disease to date. This publication provides important longer-term clinical data on the efficacy and safety of switching.","DOI":"10.1136\/annrheumdis-2016-eular.1785"},{"key":"658_CR34","doi-asserted-by":"crossref","unstructured":"\u2022 Glintborg B, Kringelbach TM, H\u00f8gdall E, S\u00f8rensen IJ, Jensen DV, Loft AG, et al. Non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis\u2014impact on s-infliximab and antidrug-antibodies. Results from the Danish Rheumatologic Biobank and the Danbio Registry. American College of Rheumatology 2016; Washington DC, USA: 2016. The DANBIO registry analysis is the largest real-world study of the effects of switching from infliximab to CT-P13 in patients with rheumatic disease to date. This publication provides important longer-term immunogenicity data on the effects of switching.","DOI":"10.1136\/annrheumdis-2016-eular.1477"},{"key":"658_CR35","doi-asserted-by":"publisher","unstructured":"Holroyd C, Parker L, Bennett S, Zarroug J, Underhill C, Davidson B, et al. Switching to biosimilar infliximab: real-world data from the Southampton biologic therapies review service. British Society for Rheumatology 2016 Annual Meeting; Glasgow, UK; Rheumatology (Oxford): 2016. doi: 10.1093\/rheumatology\/kew121.003 .","DOI":"10.1093\/rheumatology\/kew121.003"},{"key":"658_CR36","doi-asserted-by":"publisher","unstructured":"Benucci M, Gobbi FL, Bandinelli F, Damiani A, Infantino M, Grossi V, et al. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study. Immunol Res. 2016:1\u20134. doi: 10.1007\/s12026-016-8843-5 .","DOI":"10.1007\/s12026-016-8843-5"},{"key":"658_CR37","doi-asserted-by":"publisher","unstructured":"Batticciotto A, Parisi S, Gobbi FL, Antivalle M, Benucci M, Fusaro E, et al. Safety and efficacy of switching from innovator to biosimilar infliximab in patients affected by spondyloarthritis. A 6-month observational study. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. doi: 10.1136\/annrheumdis-2016-eular.5115 .","DOI":"10.1136\/annrheumdis-2016-eular.5115"},{"key":"658_CR38","doi-asserted-by":"crossref","unstructured":"Batticciotto A, Antivalle M, Gobbi FL, Parisi S, Talotta R, Varisco V, et al. Safety and efficacy of switching from originator to CT-P13 infliximab biosimilar in patients affected by spondyloarthritis. A 6-month observational study. American College of Rheumatology 2016; Washington DC, USA: Arthritis Rheumatol. 2016.","DOI":"10.1136\/annrheumdis-2016-eular.5115"},{"key":"658_CR39","doi-asserted-by":"publisher","unstructured":"Sokka T, Kautiainen H. Clinical experience with infliximab biosimilar\u2014switch from Remicade. European League Against Rheumatism 2015; Rome, Italy; Ann Rheum Dis: 2015. doi: 10.1136\/annrheumdis-2015-eular.2151 .","DOI":"10.1136\/annrheumdis-2015-eular.2151"},{"key":"658_CR40","doi-asserted-by":"publisher","first-page":"1677","DOI":"10.1517\/14712598.2015.1103733","volume":"15","author":"E Nikiphorou","year":"2015","unstructured":"Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677\u201383. doi: 10.1517\/14712598.2015.1103733 .","journal-title":"Expert Opin Biol Ther"},{"key":"658_CR41","doi-asserted-by":"publisher","unstructured":"Abdalla A, Byrne NE, Conway R, Walsh T, Mannion G, Hanly M, et al. Long term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. doi: 10.2147\/OARRR.S124975 .","DOI":"10.2147\/OARRR.S124975"},{"key":"658_CR42","unstructured":"Malaiya R, McKee Z, Kiely P. Infliximab biosimilars\u2014switching Remicade to Remsima in routine care: patient acceptability and early outcome data. British Society for Rheumatology 2016 Annual Meeting; Glasgow, UK; Rheumatology (Oxford): 2016."},{"key":"658_CR43","unstructured":"Tweehuysen L, van den Bemt BJF, van Ingen IL, de Jong AJL, van der Laan WH, van den Hoogen FHJ, et al. Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice. American College of Rheumatology 2016; Washington DC, USA: 2016."},{"key":"658_CR44","unstructured":"Buer LC, Moum BA, Cvancarova M, Warren DJ, Medhus AW, Hoivik ML. Switching from Remicade(R) to Remsima(R) is safe and feasible: a prospective, open-label study. J Crohns Colitis. 2017;11:297\u2013304."},{"key":"658_CR45","unstructured":"Bettey M, Downey L, Underhill C, Callaghan J, Rush M, Ahmed I, et al. Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016."},{"key":"658_CR46","doi-asserted-by":"publisher","first-page":"1705","DOI":"10.1111\/jgh.12997","volume":"30","author":"YS Jung","year":"2015","unstructured":"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;30:1705\u201312. doi: 10.1111\/jgh.12997 .","journal-title":"J Gastroenterol Hepatol"},{"key":"658_CR47","unstructured":"Jung YS, Park DI, Kim YH, Seo PJ, Kim JW, Kang HW. Efficacy and safety of infliximab\u2019s biosimilar (REMSIMA) for IBD. 10th Congress of the European Crohn\u2019s and Colitis Organisation; Barcelona, Spain; J Crohns Colitis: 2015."},{"key":"658_CR48","doi-asserted-by":"crossref","unstructured":"Smits L, Derikx L, Drenth J, de Jong D, van Esch A, Hoentjen F. Elective switching from Remicade\u00ae to biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016.","DOI":"10.1093\/ecco-jcc\/jjx002.787"},{"key":"658_CR49","doi-asserted-by":"crossref","first-page":"1287","DOI":"10.1093\/ecco-jcc\/jjw087","volume":"10","author":"LJT Smits","year":"2016","unstructured":"Smits LJT, Derikx LAAP, de Jong DJ, Boshuizen RS, van Esch AAJ, Drenth JPH, 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;10:1287\u201393.","journal-title":"J Crohns Colitis"},{"key":"658_CR50","unstructured":"Guerra Veloz MF, Arg\u00fcelles Arias F, Perea Amarillo R, Castro Laria L, Maldonado P\u00e9rez MB, Ben\u00edtez Rold\u00e1n A, et al. Safety and efficacy of infliximab biosimilar (Remsima\u00a9) in Crohn\u2019s disease patients in clinical practice: results after 6 months of treatment. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016a."},{"key":"658_CR51","doi-asserted-by":"crossref","unstructured":"Kolar M, Duricov\u00e1 D, Brotlik M, Hruba V, Machkova N, Mitrova K, et al. Switching of patients with inflammatory bowel disease from original infliximab (Remicade\u00ae) to biosimilar infliximab (Remsima\u2122) is effective and safe. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016.","DOI":"10.1016\/S0016-5085(16)31445-7"},{"key":"658_CR52","doi-asserted-by":"crossref","unstructured":"Kolar M, Duricov\u00e1 D, Bortlik M, Hruba V, Machkova N, Mitrova K, et al. Switching of patients with inflammatory bowel disease from original infliximab (Remicade\u00ae) to biosimilar infliximab (Remsima\u2122) is effective and safe\u2014one-year follow-up. United European Gastroenterology Week; Vienna, Austria; United European Gastroenterol J: 2016.","DOI":"10.1016\/S0016-5085(16)31445-7"},{"key":"658_CR53","unstructured":"Guerra Veloz MF, Arg\u00fcelles Arias F, Perea Amarillo R, Castro Laria L, Maldonado P\u00e9rez MB, Ben\u00edtez Rold\u00e1n A, et al. Safety and efficacy of infliximab biosimilar (Remsima\u00a9) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016b."},{"key":"658_CR54","unstructured":"Jarzebicka D, Banaszkiewicz A, Plocek A, Sieczkowska J, Gawronska A, Toporowska-Kowalska E, et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. 10th Congress of the European Crohn\u2019s and Colitis Organisation; Barcelona, Spain: 2015."},{"key":"658_CR55","doi-asserted-by":"publisher","unstructured":"Kierkus J. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. 46th Annual Digestive Disease Week; Washington DC, USA; Gastroenterology: 2015. doi: 10.1016\/S0016-5085(15)32670-6 .","DOI":"10.1016\/S0016-5085(15)32670-6"},{"key":"658_CR56","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, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Prelim Observ J Crohns Colitis. 2016;10:127\u201332.","journal-title":"Prelim Observ J Crohns Colitis"},{"key":"658_CR57","doi-asserted-by":"publisher","unstructured":"Sieczkowska J, Jarzebicka D, Oracz G, Meglicka M, Dadalski M, Kierkus J. Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn\u2019s disease. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016. doi: 10.1093\/ecco-jcc\/jjw019.736 .","DOI":"10.1093\/ecco-jcc\/jjw019.736"},{"key":"658_CR58","doi-asserted-by":"crossref","unstructured":"Hlavaty T, Krajcovicova A, Sturdik I, Letkovsky J, Koller T, Toth J, et al. Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016.","DOI":"10.14735\/amgh201627"},{"key":"658_CR59","doi-asserted-by":"crossref","unstructured":"Kang HW, Lim YJ, Kim JH, Kang YS. An experience of anti-TNF biosimilar, CT-P13 use: clinical efficacy, safety and interchangeability in inflammatory bowel disease; a pilot study. 9th Congress of the European Crohn\u2019s and Colitis Organisation; Copenhagen, Denmark; J Crohns Colitis: 2014.","DOI":"10.1016\/S1873-9946(14)60685-1"},{"key":"658_CR60","doi-asserted-by":"publisher","first-page":"951","DOI":"10.1007\/s10620-014-3392-z","volume":"60","author":"YS Kang","year":"2015","unstructured":"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;60:951\u20136. doi: 10.1007\/s10620-014-3392-z .","journal-title":"Dig Dis Sci"},{"key":"658_CR61","unstructured":"Armuzzi A. What future for biosimilars in inflammatory bowel diseases? The Italian Group for the study of Inflammatory Bowel Disease VII National Congress; Palermo, Italy: 2015."},{"key":"658_CR62","doi-asserted-by":"publisher","unstructured":"Fiorino G, Manetti N, Variola A, Bossa F, Rizzuto G, Guidi L, et al. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016. doi: 10.1097\/MIB.0000000000000995 .","DOI":"10.1097\/MIB.0000000000000995"},{"issue":"Suppl 1","key":"658_CR63","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, Kwon HJ, Lee SH, Park DI, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Exp Rev Gastroenterol Hepatol. 2015;9(Suppl 1):35\u201344.","journal-title":"Exp Rev Gastroenterol Hepatol"},{"key":"658_CR64","doi-asserted-by":"publisher","first-page":"736","DOI":"10.1016\/j.jaad.2016.04.068","volume":"75","author":"PMD Dapavo","year":"2016","unstructured":"Dapavo PMD, Vujic IMD, Fierro MTMD, Quaglino PMD, Sanlorenzo MMD. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75:736\u20139. doi: 10.1016\/j.jaad.2016.04.068 .","journal-title":"J Am Acad Dermatol"},{"key":"658_CR65","unstructured":"\u2022 J\u00f8rgensen K, Olsen I, Goll G, Lorentzen M, Bolstad N, Haavardsholm E, et al. Biosimilar infliximab (CT-P13) is not inferior to originator Infliximab: results from the 52-week randomized NOR-SWITCH trial. United European Gastroenterology Week; Vienna, Austria; United European Gastroenterol J: 2016. The NOR-SWITCH study is the largest clinical trial of switching from infliximab to CT-P13 and includes patients from multiple indications. This study provides important efficacy, safety and immunogenicity data on switching."},{"key":"658_CR66","unstructured":"\u2022 Goll GL, Olsen IC, Jorgensen KK, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from a 52-week randomized switch trial in Norway. American College of Rheumatology 2016; Washington DC, USA; Arthritis Rheumatol: 2016. The NOR-SWITCH study is the largest clinical trial of switching from infliximab to CT-P13 and includes patients from multiple indications. This study provides important efficacy, safety and immunogenicity data on switching."},{"key":"658_CR67","doi-asserted-by":"crossref","first-page":"1677","DOI":"10.1517\/14712598.2015.1103733","volume":"15","author":"S Gentileschi","year":"2015","unstructured":"Gentileschi S, Barreca C, Bellisai F, Biasi G, Brizi MG, De Stefano R, et al. Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases: response to: Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677\u201383. Expert Opin Biol Ther. 2016;16:1311-2","journal-title":"Expert Opin Biol Ther"},{"key":"658_CR68","unstructured":"JAPIC Clinical Trials Information. Extension study following the phase I\/II clinical study of CT-P13 in the patients with rheumatoid arthritis (JapicCTI-142703). http:\/\/www.clinicaltrials.jp\/user\/cteSearch_e.jsp . Accessed 24 Mar 2016."},{"key":"658_CR69","unstructured":"EU Clinical Trials Register. SIMILAR Trial: Santeon InflixMab biosimILAr Research. A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2009-013129-41\/NL . Accessed 22 Mar 2016."},{"key":"658_CR70","unstructured":"ClinicalTrials.gov. Demonstrate noninferiority in efficacy and to assess safety of CT-P13 in patients with active Crohn\u2019s disease. http:\/\/clinicaltrials.gov\/ct2\/show\/NCT02096861 . Accessed 28 Apr 2016."},{"key":"658_CR71","unstructured":"ClinicalTrials.gov. Post-marketing use of inflectra (infliximab) for standard of care treatment of inflammatory bowel disease (CONNECT-IBD). http:\/\/clinicaltrials.gov\/ct2\/show\/NCT02539368 . Accessed 23 Mar 2016."},{"key":"658_CR72","unstructured":"EU Clinical Trials Register. An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima\u2122 (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn\u2019s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2014-004904-31\/NL . Accessed 22 Mar 2016."},{"key":"658_CR73","doi-asserted-by":"publisher","unstructured":"\u2022 Smolen J, Choe JY, Prodanovic N, Niebrzdowski J, Staykov I, Dokoupilova E, et al. Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. doi: 10.1136\/annrheumdis-2016-eular.3122 . Only published study to date of switching from infliximab to SB2. This study provides important efficacy, safety and immunogenicity data on switching.","DOI":"10.1136\/annrheumdis-2016-eular.3122"},{"key":"658_CR74","doi-asserted-by":"crossref","unstructured":"\u2022 Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Comparable safety and immunogenicity and sustained efficacy after transition to SB2 (an infliximab biosimilar) vs ongoing reference infliximab (Remicade\u00ae) in patients with rheumatoid arthritis: results of phase III transition study. American College of Rheumatology 2016; Washington DC, USA: 2016. Only published study to date of switching from infliximab to SB2. This study provides important efficacy, safety and immunogenicity data on switching.","DOI":"10.1136\/annrheumdis-2016-eular.3122"},{"key":"658_CR75","unstructured":"Hamanaka S, Nakagawa T, Koseki H, Sakurai T, Taida T, Okimoto K, et al. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016."},{"key":"658_CR76","doi-asserted-by":"publisher","unstructured":"D\u00edaz Hern\u00e1ndez L, Rodr\u00edguez Gonz\u00e1lez GE, Vela Gonz\u00e1lez M, Tardillo Mar\u00edn CA, Rodr\u00edguez D\u00edaz CY, Arranz Hern\u00e1ndez L 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. 11th Congress of the European Crohn\u2019s and Colitis Organisation; Amsterdam, The Netherlands: 2016. doi: 10.1093\/ecco-jcc\/jjw019.568 .","DOI":"10.1093\/ecco-jcc\/jjw019.568"},{"key":"658_CR77","unstructured":"UMIN-CTR Clinical Trial. To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. https:\/\/upload.umin.ac.jp\/cgi-open-bin\/ctr_e\/ctr_view.cgi?recptno=R000024788 . Accessed 09 Sept 2016."},{"key":"658_CR78","doi-asserted-by":"crossref","unstructured":"\u2022 Emery P, Vencovsk\u00fd J, Sylwestrzak A, Leszczynski P, Porawska W, Stasiuk B, et al. Longterm safety and efficacy of SB4 (etanercept biosimilar) in patients with rheumatoid arthritis: comparison between continuing SB4 and switching from etanercept reference product to SB4. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. Only published study to date of switching from etanercept to SB4 in patients with RA. This study provides important efficacy, safety and immunogenicity data on switching.","DOI":"10.1136\/annrheumdis-2016-eular.3137"},{"key":"658_CR79","doi-asserted-by":"crossref","unstructured":"\u2022 Emery P, Vencovsk\u00fd J, Sylwestrzak A, Leszczynski P, Porawska W, Stasiuk B, et al. Additional efficacy results of SB4 (etanercept biosimilar) up to week 100: comparison between continuing SB4 and switching from reference etanercept (Enbrel\u00ae) to SB4. American College of Rheumatology 2016; Washington DC, USA: 2016. Ann Rheum Dis: 2016;75(Suppl2):236. Only published study to date of switching from etanercept to SB4 in patients with RA. This study provides important efficacy, safety and immunogenicity data on switching.","DOI":"10.1136\/annrheumdis-2016-eular.3137"},{"key":"658_CR80","doi-asserted-by":"publisher","unstructured":"Lee Y, Shin D, Kim Y, Kang J, Gauliard A, Fuhr R. A randomised Phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel(R)) in healthy subjects. Br J Clin Pharmacol. 2016;82:64\u201373. doi: 10.1111\/bcp.12929 .","DOI":"10.1111\/bcp.12929"},{"key":"658_CR81","doi-asserted-by":"crossref","unstructured":"Lee YJ, Shin D, Kim Y, Kang JW, Fuhr R, Gauliard A. A phase I pharmacokinetic study comparing SB4, an etanercept biosimilar, and etanercept reference product (Enbrel\u00ae) in healthy male subjects. European League Against Rheumatism 2015; Rome, Italy; Ann Rheum Dis: 2015.","DOI":"10.1111\/bcp.12929"},{"key":"658_CR82","unstructured":"Nederlands Trial Register. Switching treatment from innovator etanercept (Enbrel) to etanercept biosimilar (Benepali) in patients with a rheumatic disease in daily clinical care. http:\/\/www.trialregister.nl\/trialreg\/admin\/rctview.asp?TC=5901 . Accessed 19 Sept 2016."},{"key":"658_CR83","doi-asserted-by":"crossref","unstructured":"\u2022 Griffiths CE, Thaci D, Gerdes S, Arenberger P, Pulka G, Kingo K, et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis. Br J Dermatol. 2017;176:928\u201338. Only published study to date of switching from etanercept to GP2015 in patients. Interchangeability design with 2 control treatment arms allows effect of multiple switching to be assessed. This study also provides important efficacy, safety and immunogenicity data on switching.","DOI":"10.1111\/bjd.15152"},{"key":"658_CR84","doi-asserted-by":"publisher","unstructured":"Afonso M, Sanguino Heinrich S, Poetzl J, Woehling H. Pharmacokinetics and safety of GP2015, a proposed etanercept biosimilar, and etanercept originator product in healthy male subjects: a randomised twoway crossover study. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. doi: 10.1136\/annrheumdis-2016-eular.1422 .","DOI":"10.1136\/annrheumdis-2016-eular.1422"},{"key":"658_CR85","unstructured":"EU Clinical Trials Register. A randomized, double-blind, parallel-group phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel\u00ae (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis. http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2012-002009-23 . Accessed 26 Mar 2016,"},{"key":"658_CR86","doi-asserted-by":"publisher","first-page":"177","DOI":"10.2165\/11631860-000000000-00000","volume":"26","author":"S Yi","year":"2012","unstructured":"Yi S, Kim SE, Park MK, Yoon SH, Cho JY, Lim KS, et al. Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel(R)): a double-blind, single-dose, crossover study in healthy volunteers. BioDrugs. 2012;26:177\u201384. doi: 10.2165\/11631860-000000000-00000 .","journal-title":"BioDrugs"},{"key":"658_CR87","unstructured":"ClinicalTrials.gov. Comparison of CHS-0214 to enbrel (Etanercept) in patients with rheumatoid arthritis (RA) (CHS-0214-02). http:\/\/clinicaltrials.gov\/ct2\/show\/NCT02115750 . Accessed 26 Mar 2016."},{"key":"658_CR88","unstructured":"Chung H, Ahn L, Choi Y, Shin S, Jang I, Yu K, et al. LBEC0101, an etanercept biosimilar, showed comparable tolerability and pharmacokinetic profiles to those of etanercept in healthy male volunteers. 115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; Atlanta, Georgia, USA; Clin Pharmacol Ther. 95:S5\u2013S6."},{"key":"658_CR89","unstructured":"ClinicalTrials.gov. Study to compare the safety and pharmacokinetic characteristics of LBEC0101 25 mg with those of Enbrel\u00ae. http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01145950 . Accessed 26 Mar 2016."},{"key":"658_CR90","unstructured":"ClinicalTrials.gov. A study to evaluate the long-term safety and efficacy of LBEC0101 in subjects with active rheumatoid arthritis despite methotrexate (MTX). http:\/\/clinicaltrials.gov\/ct2\/show\/NCT02715908 . Accessed 26 Mar 2016."},{"key":"658_CR91","unstructured":"Gu N, Kim BR, Kim BH, Kim JW, Song DH, Shin SG, et al. Comparative pharmacokinetics\/tolerability of TuNEX and Enbrel\u00ae in healthy Korean volunteers. 111th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; Atlanta, Georgia, USA; Clin Pharmacol Ther: 2010."},{"key":"658_CR92","doi-asserted-by":"publisher","first-page":"2029","DOI":"10.1016\/j.clinthera.2011.10.022","volume":"33","author":"N Gu","year":"2011","unstructured":"Gu N, Yi S, Kim TE, Kim J, Shin SG, Jang IJ, et al. Comparative pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg): a randomized, open-label, single-dose, two-sequence, crossover study in healthy Korean male volunteers. Clin Ther. 2011;33:2029\u201337. doi: 10.1016\/j.clinthera.2011.10.022 .","journal-title":"Clin Ther"},{"key":"658_CR93","unstructured":"\u2022 Cohen S, Pablos JL, Zhang N, Rizzo W, Muller G, Padmanaban D, et al. ABP 501 long-term safety\/efficacy: interim results from an open-label extension study. American College of Rheumatology 2016; Washington DC, USA; 2016;68(suppl 10). http:\/\/acrabstracts.org\/abstract\/abp-501-long-term-safetyefficacy-interim-results-from-an-open-label-extension-study\/ . Accessed 17 May 2017. Only published study to date of switching from adalimumab to ABP 501 in patients with RA. This study provides important efficacy, safety and immunogenicity data on switching."},{"key":"658_CR94","doi-asserted-by":"crossref","unstructured":"Strober B, Foley P, Kaur P, Philipp S, Zhang N. Evaluation of efficacy and safety of ABP 501 in a phase 3 study in subjects with moderate to severe plaque psoriasis: 52-week results. American Academy of Dermatology 74th Annual Meeting; Washington DC, USA; J Am Acad Dermatol: 2016.","DOI":"10.1016\/j.jaad.2016.02.972"},{"key":"658_CR95","doi-asserted-by":"crossref","unstructured":"Gooderham M, Constanzo A, Kaliaperumal A, Kaur P, Narbutt J, Spelman L, et al. Single transition from adalimumab to ABP 501: evaluation of immunogenicity in a phase 3 study in subjects with moderate to severe plaque psoriasis. American Academy of Dermatology 74th Annual Meeting; Washington DC, USA; J Am Acad Dermatol: 2016.","DOI":"10.1016\/j.jaad.2016.02.1060"},{"key":"658_CR96","doi-asserted-by":"crossref","unstructured":"\u2022 Weinblatt M, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Sitek-Ziolkowska K, et al. Sustained efficacy and comparable safety and immunogenicity after transition to SB5 (an adalimumab biosimilar) vs continuation of the adalimumab reference product in patients with rheumatoid arthritis: result of phase III study. European League Against Rheumatism 2016; London, UK; Ann Rheum Dis: 2016. Only published study to date of switching from adalimumab to SB5 in patients with RA. This study provides important immunogenicity data on switching, although efficacy and safety data are lacking.","DOI":"10.1136\/annrheumdis-2016-eular.1762"},{"key":"658_CR97","unstructured":"\u2022 Genovese MC, Weinblatt M, Keystone EC, Baranauskaite A, Cheong SY, Ghil J. Efficacy after transition to SB5 from reference adalimumab (Humira\u00ae) vs. continuation of SB5 or reference adalimumab by antibodies developed after transition from a SB5 phase III study. American College of Rheumatology 2016; Washington DC, USA: 2016. Only published study to date of switching from adalimumab to SB5 in patients with RA. This study provides important immunogenicity data on switching, although efficacy and safety data are lacking."},{"key":"658_CR98","doi-asserted-by":"crossref","unstructured":"EU Clinical Trials Register. A phase 3 randomized, double-blind, multicenter study to evaluate efficacy, safety, and immunogenicity of an adalimumab biosimilar (M923) and Humira\u00ae in subjects with moderate to severe chronic plaque-type psoriasis. http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2015-001751-76\/SK . Accessed 22 Apr 2016.","DOI":"10.1016\/j.jaad.2017.04.106"},{"key":"658_CR99","unstructured":"\u2022 Yoo DH, Park W, Suh CH, Shim SC, Cons Molina F, Jeka S, et al. Efficacy and safety of switched CT-P10 from innovator rituximab compared to those of maintained CT-P10 in patients with rheumatoid arthritis up to 56 weeks. American College of Rheumatology 2015; San Francisco, California, USA; Arthritis Rheumatol: 2015. Only published study to date of switching from rituximab to CT-P10 in patients with RA. This study provides important efficacy and safety data on switching, although immunogenicity data are lacking."},{"key":"658_CR100","unstructured":"ClinicalTrials.gov. GP2013 treatment in patients with active rheumatoid arthritis, previously treated with Rituxan\u00ae or MabThera\u00ae (ASSIST-RT). http:\/\/clinicaltrials.gov\/show\/NCT02514772 . Accessed 29 May 2016."},{"key":"658_CR101","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13075-015-0906-9","volume":"18","author":"DH Yoo","year":"2016","unstructured":"Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, 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;18:1\u201312.","journal-title":"Arthritis Res Ther"},{"key":"658_CR102","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, Brzezicki J, Gnylorybov A, Kadinov V, 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"},{"key":"658_CR103","doi-asserted-by":"publisher","first-page":"817","DOI":"10.3109\/14397595.2015.1022297","volume":"25","author":"T Takeuchi","year":"2015","unstructured":"Takeuchi T, Yamanaka H, Tanaka Y, Sakurai T, Saito K, Ohtsubo H, 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;25:817\u201324. doi: 10.3109\/14397595.2015.1022297 .","journal-title":"Mod Rheumatol"},{"key":"658_CR104","doi-asserted-by":"publisher","first-page":"1605","DOI":"10.1136\/annrheumdis-2012-203091","volume":"72","author":"W Park","year":"2013","unstructured":"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;72:1605\u201312. doi: 10.1136\/annrheumdis-2012-203091 .","journal-title":"Ann Rheum Dis"},{"key":"658_CR105","doi-asserted-by":"publisher","first-page":"1203","DOI":"10.3899\/jrheum.091042","volume":"37","author":"RD Inman","year":"2010","unstructured":"Inman RD, Maksymowych WP. A double-blind, placebo-controlled trial of low dose infliximab in ankylosing spondylitis. J Rheumatol. 2010;37:1203\u201310. doi: 10.3899\/jrheum.091042 .","journal-title":"J Rheumatol"},{"key":"658_CR106","doi-asserted-by":"publisher","first-page":"1270","DOI":"10.1002\/art.24001","volume":"59","author":"J Braun","year":"2008","unstructured":"Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum. 2008;59:1270\u20138. doi: 10.1002\/art.24001 .","journal-title":"Arthritis Rheum"},{"key":"658_CR107","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1002\/art.23167","volume":"58","author":"M Breban","year":"2008","unstructured":"Breban M, Ravaud P, Claudepierre P, Baron G, Henry YD, Hudry C, et al. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 2008;58:88\u201397. doi: 10.1002\/art.23167 .","journal-title":"Arthritis Rheum"},{"key":"658_CR108","doi-asserted-by":"publisher","first-page":"859","DOI":"10.1093\/rheumatology\/kel015","volume":"45","author":"L Gossec","year":"2006","unstructured":"Gossec L, Le Henanff A, Breban M, Vignon E, Claudepierre P, Devauchelle V, et al. Continuation of treatment with infliximab in ankylosing spondylitis: 2-yr open follow-up. Rheumatology (Oxford). 2006;45:859\u201362. doi: 10.1093\/rheumatology\/kel015 .","journal-title":"Rheumatology (Oxford)"},{"key":"658_CR109","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1136\/ard.2004.025130","volume":"64","author":"J Braun","year":"2005","unstructured":"Braun J, Brandt J, Listing J, Zink A, Alten R, Burmester G, et al. Two year maintenance of efficacy and safety of infliximab in the treatment of ankylosing spondylitis. Ann Rheum Dis. 2005;64:229\u201334.","journal-title":"Ann Rheum Dis"},{"key":"658_CR110","doi-asserted-by":"crossref","first-page":"1218","DOI":"10.1136\/ard.2003.014258","volume":"62","author":"TI Temekonidis","year":"2003","unstructured":"Temekonidis TI, Alamanos Y, Nikas SN, Bougias DV, Georgiadis AN, Voulgari PV, et al. Infliximab therapy in patients with ankylosing spondylitis: an open label 12 month study. Ann Rheum Dis. 2003;62:1218\u201320.","journal-title":"Ann Rheum Dis"},{"key":"658_CR111","doi-asserted-by":"publisher","unstructured":"Vencovsk\u00fd J, Sylwestrzak A, Leszczy\u0144ski P, Porawska W, Baranauskaite A, Tseluyko V, et al. A phase III, randomized, double-blind clinical study comparing SB4, an etanercept biosimilar, with etanercept reference product (Enbrel\u00ae) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (52-week results). American College of Rheumatology 2015; San Francisco, California, USA; Arthritis Rheum: 2015. doi: 10.1136\/annrheumdis-2015-eular.1220 .","DOI":"10.1136\/annrheumdis-2015-eular.1220"},{"key":"658_CR112","doi-asserted-by":"publisher","first-page":"e64","DOI":"10.1136\/annrheumdis-2016-210101","volume":"75","author":"M Scheinberg","year":"2016","unstructured":"Scheinberg M, Azevedo V. Difference between enbrel and benepali treatment groups in \u2018hepatobiliary disorders\u2019. Ann Rheum Dis. 2016;75:e64. doi: 10.1136\/annrheumdis-2016-210101 .","journal-title":"Ann Rheum Dis"},{"key":"658_CR113","doi-asserted-by":"publisher","unstructured":"Emery P, Vencovsk\u00fd J, Ghil J, Cheong SY, Rho YH. Difference between SB4 and reference etanercept in the hepatobiliary disorders not considered to be caused by SB4: response to letter by Scheinberg and Azevedo. Ann Rheum Dis. 2016;75:e65. doi: 10.1136\/annrheumdis-2016-210127 .","DOI":"10.1136\/annrheumdis-2016-210127"},{"key":"658_CR114","unstructured":"Yoo DH, Park W, Jeka S, Cons Molina F, Hrycaj P, Wiland P, et al. A randomized, controlled, multicenter, 2-arm, parallel-group, double-blind study to demonstrate the equivalence of CT-P10 to innovator rituximab with respect to pharmacokinetic profile in patients with rheumatoid arthritis. American College of Rheumatology 2013; San Diego, California, USA: 2013."},{"key":"658_CR115","first-page":"s331","volume":"21","author":"SC Singh","year":"2015","unstructured":"Singh SC, Bagnato KM. The economic implications of biosimilars. Am J Manag Care. 2015;21:s331\u2013s40.","journal-title":"Am J Manag Care"},{"key":"658_CR116","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1208\/s12248-013-9534-y","volume":"16","author":"H Lee","year":"2014","unstructured":"Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J. 2014;16:22\u20136. doi: 10.1208\/s12248-013-9534-y .","journal-title":"AAPS J"},{"key":"658_CR117","unstructured":"Flood J, Mihalik C, Fleming RR, Strober BE, Zucker DR, Burgoyne DS. The use of therapeutic interchange for biologic therapies. Manag Care. 2007;16:51\u201362."},{"key":"658_CR118","unstructured":"inVentiv Health Clinical. Elderly representation in clinical trials: not a gray area. http:\/\/www.inventivhealthclinical.com\/resource-library-white-papers.htm . Accessed 10 Mar 2016."},{"key":"658_CR119","unstructured":"Chu R, Torstensson D, Pugatch M. Patient safety and comfort. The challenges of switching medicines. Stockholm Network. 2010. http:\/\/www.patients-rights.org\/uploadimages\/Patient_Safety_and_Comfort_The_Challenges_of_Switching.pdf . Accessed 31 Mar 2016."}],"container-title":["Current Rheumatology Reports"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s11926-017-0658-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11926-017-0658-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11926-017-0658-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T17:57:44Z","timestamp":1750355864000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s11926-017-0658-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6]]},"references-count":119,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2017,6]]}},"alternative-id":["658"],"URL":"https:\/\/doi.org\/10.1007\/s11926-017-0658-4","relation":{},"ISSN":["1523-3774","1534-6307"],"issn-type":[{"value":"1523-3774","type":"print"},{"value":"1534-6307","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,6]]},"article-number":"37"}}