Biosimilars for Psoriasis: Clinical Studies to Determine Similarity

A Blauvelt; L Puig; S Chimenti; R Vender; M Rajagopalan; R Romiti; L Skov; C Zachariae; H Young; E Prens; A Cohen; J van der Walt; J J Wu

doi:10.1111/bjd.15067

Biosimilars for Psoriasis: Clinical Studies to Determine Similarity

A Blauvelt, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, L Skov, C Zachariae, H Young, E Prens, A Cohen, J van der Walt, J J Wu

Afdeling for Allergi, Hud- og Kønssygdomme HGH

18 Citationer (Scopus)

Abstract

Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine 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. This article is protected by copyright. All rights reserved.

Originalsprog	Engelsk
Tidsskrift	British Journal of Dermatology
Vol/bind	177
Udgave nummer	1
Sider (fra-til)	23-33
ISSN	0007-0963
DOI	https://doi.org/10.1111/bjd.15067
Status	Udgivet - jul. 2017

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10.1111/bjd.15067

Citationsformater

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title = "Biosimilars for Psoriasis: Clinical Studies to Determine Similarity",

abstract = "Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine 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. This article is protected by copyright. All rights reserved.",

author = "A Blauvelt and L Puig and S Chimenti and R Vender and M Rajagopalan and R Romiti and L Skov and C Zachariae and H Young and E Prens and A Cohen and {van der Walt}, J and Wu, {J J}",

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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

PY - 2017/7

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N2 - Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine 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. This article is protected by copyright. All rights reserved.

AB - Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine 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. This article is protected by copyright. All rights reserved.

U2 - 10.1111/bjd.15067

DO - 10.1111/bjd.15067

M3 - Review

C2 - 27639072

SN - 0007-0963

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SP - 23

EP - 33

JO - British Journal of Dermatology

JF - British Journal of Dermatology

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ER -

Biosimilars for Psoriasis: Clinical Studies to Determine Similarity

Abstract

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