86427 20200609132538.0 doi 10.1080/14712598.2019.1561851 sideral 110867 ART-2018-110867 eng Gimeno-Gracia, M. Bioequivalence studies with anti-TNF biosimilars 2018 Access copy available to the general public Unrestricted Introduction: Biosimilars, as defined by the European Medicines Agency, have been used in Europe since 2006. The landscape was considerably expanded when the first biosimilar of a monoclonal was approved and introduced in the European market. CT-P13 was developed by Celltrion as an infliximab biosimilar in 2013, not without controversy. As these complex molecules cannot be completely identical, some experts, clinicians, and even patients were skeptical regarding the real bioequivalence of the drugs. Currently, several new infliximab and adalimumab biosimilars are available or will reach the market in a few months. Areas covered: Our goal is to review, mainly from a clinical perspective, the available evidence for bioequivalence of anti-TNF biosimilars. We aim to take into account not only preclinical studies, mostly done for regulatory issues, but also data from clinical studies. Expert opinion: We can conclude that bioequivalence with originator is well demonstrated in those drugs which have followed European Medicines Agency regulatory pathways. Switching from originator to biosimilar appears safe for all indications. However, there are few data available for switching from one biosimilar to another, or for complete interchangeability. Prospective studies and strict pharmacovigilance are recommended. info:eu-repo/semantics/openAccess All rights reserved http://www.europeana.eu/rights/rr-f/ 3.585 2018 MEDICINE, RESEARCH & EXPERIMENTAL 49 / 135 = 0.363 2018 Q2 T2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY 44 / 162 = 0.272 2018 Q2 T1 1.133 2018 Clinical Biochemistry 2018 Q1 Pharmacology 2018 Q1 Drug Discovery 2018 Q1 info:eu-repo/semantics/article info:eu-repo/semantics/submittedVersion (orcid)0000-0002-3545-2707 Gargallo-Puyuelo, C.J. Universidad de Zaragoza (orcid)0000-0003-0076-3529 Gomollón, F. Universidad de Zaragoza 1007 610 Universidad de Zaragoza Dpto. Medicina, Psiqu. y Derm. Area Medicina 19, 10 (2018), 1031 - 1043 Expert Opin. Biol. Ther. EXPERT OPINION ON BIOLOGICAL THERAPY 1471-2598 306575 http://zaguan.unizar.es/record/86427/files/texto_completo.pdf Preprint 43655 http://zaguan.unizar.es/record/86427/files/texto_completo.jpg?subformat=icon icon Preprint oai:zaguan.unizar.es:86427 articulos driver 2020-06-09-13:24:35 ARTICLE