000086427 001__ 86427 000086427 005__ 20200609132538.0 000086427 0247_ $$2doi$$a10.1080/14712598.2019.1561851 000086427 0248_ $$2sideral$$a110867 000086427 037__ $$aART-2018-110867 000086427 041__ $$aeng 000086427 100__ $$aGimeno-Gracia, M. 000086427 245__ $$aBioequivalence studies with anti-TNF biosimilars 000086427 260__ $$c2018 000086427 5060_ $$aAccess copy available to the general public$$fUnrestricted 000086427 5203_ $$aIntroduction: 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. 000086427 540__ $$9info:eu-repo/semantics/openAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/ 000086427 590__ $$a3.585$$b2018 000086427 591__ $$aMEDICINE, RESEARCH & EXPERIMENTAL$$b49 / 135 = 0.363$$c2018$$dQ2$$eT2 000086427 591__ $$aBIOTECHNOLOGY & APPLIED MICROBIOLOGY$$b44 / 162 = 0.272$$c2018$$dQ2$$eT1 000086427 592__ $$a1.133$$b2018 000086427 593__ $$aClinical Biochemistry$$c2018$$dQ1 000086427 593__ $$aPharmacology$$c2018$$dQ1 000086427 593__ $$aDrug Discovery$$c2018$$dQ1 000086427 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/submittedVersion 000086427 700__ $$0(orcid)0000-0002-3545-2707$$aGargallo-Puyuelo, C.J.$$uUniversidad de Zaragoza 000086427 700__ $$0(orcid)0000-0003-0076-3529$$aGomollón, F.$$uUniversidad de Zaragoza 000086427 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000086427 773__ $$g19, 10 (2018), 1031 - 1043$$pExpert Opin. Biol. Ther.$$tEXPERT OPINION ON BIOLOGICAL THERAPY$$x1471-2598 000086427 8564_ $$s306575$$uhttps://zaguan.unizar.es/record/86427/files/texto_completo.pdf$$yPreprint 000086427 8564_ $$s43655$$uhttps://zaguan.unizar.es/record/86427/files/texto_completo.jpg?subformat=icon$$xicon$$yPreprint 000086427 909CO $$ooai:zaguan.unizar.es:86427$$particulos$$pdriver 000086427 951__ $$a2020-06-09-13:24:35 000086427 980__ $$aARTICLE