Biosimilars for psoriasis: clinical studies to determine similarity

TY - JOUR

T1 - Biosimilars for psoriasis

T2 - clinical studies to determine similarity

AU - Blauvelt, A

AU - Puig, L

AU - Chimenti, S

AU - Vender, R

AU - Rajagopalan, M

AU - Romiti, R

AU - Skov, L.

AU - Zachariae, C

AU - Young, H

AU - Prens, E

AU - Cohen, A

AU - van der Walt, J

AU - Wu, J J

N1 - This article is protected by copyright. All rights reserved.

PY - 2017/7

Y1 - 2017/7

N2 - 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.

AB - 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.

U2 - 10.1111/bjd.15067

DO - 10.1111/bjd.15067

M3 - Review

C2 - 27639072

SN - 0007-0963

VL - 177

SP - 23

EP - 33

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 1

ER -