title: Biosimilars in inflammatory bowel diseases: an important moment for Brazilian gastroenterologists.
abstract: Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn's disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.
authors.affiliation: Clínica Gastrosaúde, Marília, SP, Brasil.
authors.forename: Fábio Vieira
authors.initials: FV
authors.lastname: Teixeira
authors.affiliation: Serviço de Coloproctologia, Hospital Universitário Cajuru - SeCoHUC - PUCPR, Curitiba, PR, Brasil.
authors.forename: Paulo Gustavo
authors.initials: PG
authors.lastname: Kotze
authors.affiliation: Serviço de Gastroenterologia, Faculdade de Medicina, Universidade de São Paulo - FMUSP, São Paulo, SP, Brasil.
authors.forename: Aderson Omar Mourão Cintra
authors.initials: AO
authors.lastname: Damião
authors.affiliation: Serviço de Gastroenterologia, Escola Paulista de Medicina - UNIFESP, São Paulo, SP, Brasil.
authors.forename: Sender Jankiel
authors.initials: SJ
authors.lastname: Miszputen
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects* / Q000138:chemical synthesis / Q000627:therapeutic use; D001938:Brazil; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000503:physiopathology; D003424:Crohn Disease / Q000188:drug therapy / Q000503:physiopathology; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy; D000069285:Infliximab
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents; D000069285:Infliximab