Premium
Biosimilars for psoriasis: clinical studies to determine similarity
Author(s) -
Blauvelt A.,
Puig L.,
Chimenti S.,
Vender R.,
Rajagopalan M.,
Romiti R.,
Skov L.,
Zachariae C.,
Young H.,
Prens E.,
Cohen A.,
Walt J.,
Wu J.J.
Publication year - 2017
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.15067
Subject(s) - biosimilar , interchangeability , medicine , psoriasis , clinical trial , similarity (geometry) , intensive care medicine , medical physics , pharmacology , dermatology , computer science , artificial intelligence , image (mathematics) , programming language
Summary 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.