Biosimilars for psoriasis: clinical studies to determine similarity.

Authors :: Blauvelt A
Puig L
Chimenti S
Vender R
Rajagopalan M
Romiti R
Skov L
Zachariae C
Young H
Prens E
Cohen A
van der Walt J
Wu JJ
Source :: The British journal of dermatology [Br J Dermatol] 2017 Jul; Vol. 177 (1), pp. 23-33. Date of Electronic Publication: 2017 May 28.
Publication Year :: 2017
Abstract: Biosimilars 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.<br /> (© 2016 British Association of Dermatologists.)