{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T18:49:20Z","timestamp":1791485360721,"version":"4.3.4"},"reference-count":57,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,11,8]],"date-time":"2018-11-08T00:00:00Z","timestamp":1541635200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Biosimilar versions of widely prescribed drugs, including the tumour\u2010necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability,\n                      <jats:styled-content style=\"fixed-case\">US<\/jats:styled-content>\n                      Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non\u2010inferior to a reference product after multiple switches between products.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Published studies presenting data on switching between reference and biosimilar infliximab were identified by searching the\n                      <jats:styled-content style=\"fixed-case\">MEDLINE<\/jats:styled-content>\n                      database. Congress abstracts were identified by searching the\n                      <jats:styled-content style=\"fixed-case\">EMBASE<\/jats:styled-content>\n                      database and manually searching abstracts from relevant congresses.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 113 journal articles and 149 abstracts were found. Of these, 70 were considered relevant and included in this analysis. Most of the publications were uncontrolled, observational studies. Data from six randomised, controlled trials were identified. In general, the evidence revealed no clinically important efficacy or safety signals associated with switching.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>While available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.14997","type":"journal-article","created":{"date-parts":[[2018,11,9]],"date-time":"2018-11-09T00:49:29Z","timestamp":1541724569000},"page":"31-40","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":70,"title":["Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab"],"prefix":"10.1111","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6914-3822","authenticated-orcid":false,"given":"Brian G.","family":"Feagan","sequence":"first","affiliation":[{"name":"Robarts Research Institute Western University London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordon","family":"Lam","sequence":"additional","affiliation":[{"name":"Carolinas Healthcare System Concord North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Ma","sequence":"additional","affiliation":[{"name":"University of Calgary Calgary ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1913-2957","authenticated-orcid":false,"given":"Gary R.","family":"Lichtenstein","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine of the University of Pennsylvania Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,8]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"351","volume-title":"The Biomanufacturing of Biotechnology Products. 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