Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSPBLAUVELT, A.PUIG, L.CHIMENTI, S.VENDER, R.RAJAGOPALAN, M.ROMITI, R.SKOV, L.ZACHARIAE, C.YOUNG, H.PRENS, E.COHEN, A.WALT, J. van derWU, J. J.2017-08-172017-08-172017BRITISH JOURNAL OF DERMATOLOGY, v.177, n.1, p.23-33, 20170007-0963https://observatorio.fm.usp.br/handle/OPI/21509Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.engrestrictedAccessplaque psoriasisdouble-blindphase-iiiextrapolationtrialinfliximabtherapyinterchangeabilityrheumatologyadalimumabarticleCopyright WILEY10.1111/bjd.15067Dermatology1365-2133