{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,4,5]],"date-time":"2022-04-05T04:11:22Z","timestamp":1649131882485},"reference-count":77,"publisher":"Bentham Science Publishers Ltd.","issue":"2","content-domain":{"domain":["eurekaselect.com"],"crossmark-restriction":true},"short-container-title":["CMC"],"published-print":{"date-parts":[[2019,3,14]]},"abstract":"<jats:sec>\n<jats:title \/>\n<jats:p>Immune-mediated inflammatory diseases share several pathogenic pathways and\nthis pushes sometimes to extrapolate from one disease or indication to others. A biosimilar\ncan be defined as a biotherapeutic product which is similar in terms of quality, safety, and efficacy\nto an already licensed reference biotherapeutic product. We review the substrate for\nextrapolation, the current approval process for biosimilars and the pioneering studies on\nbiosimilars performed in rheumatoid arthritis patients. A biosimilar has the same amino acid\nsequence as its innovator product. However, post-translational modifications can occur and\nthe current analytical techniques do not allow the final structure. To test the efficacy in one\nindication, a homogeneous population should be chosen and immunogenicity features are essential\nin switching and interchangeability. CT-P13 (Remsima\u2122; Inflectra\u2122) is a biosimilar\nof reference infliximab (Remicade\u00ae). It meets most of the requirements for extrapolation.\nNevertheless, in inflammatory bowel diseases (IBD) we need more studies to confirm the postulates\nof extrapolation from rheumatoid arthritis and ankylosing spondylitis to IBD. Furthermore,\nan effective pharmacovigilance schedule is mandatory to look for immunogenicity and\nside effects.<\/jats:p>\n<\/jats:sec>","DOI":"10.2174\/0929867325666181101114937","type":"journal-article","created":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T07:53:13Z","timestamp":1541058793000},"page":"248-258","update-policy":"http:\/\/dx.doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Can We Extrapolate Data from One Immune-Mediated Inflammatory Disease to Another One?"],"prefix":"10.2174","volume":"26","author":[{"given":"Fernando","family":"Magro","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Faculty of Medicine, Centro Hospitalar Sao Joao, Porto, Portugal"}]},{"given":"Rosa","family":"Coelho","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Faculty of Medicine, Centro Hospitalar Sao Joao, Porto, Portugal"}]},{"given":"Armando","family":"Peixoto","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Faculty of Medicine, Centro Hospitalar Sao Joao, Porto, Portugal"}]}],"member":"965","reference":[{"key":"ref=1","unstructured":""},{"key":"ref=2","unstructured":""},{"key":"ref=3","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1002\/cam4.258","volume":"3","author":"Camacho L.H.","year":"2014","unstructured":"Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S.  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