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

Research output: Contribution to journal › Review article › peer-review

17 Scopus citations

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.

Original language	English
Pages (from-to)	23-33
Number of pages	11
Journal	British Journal of Dermatology
Volume	177
Issue number	1
DOIs	https://doi.org/10.1111/bjd.15067
State	Published - 1 Jul 2017

ASJC Scopus subject areas

Dermatology

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10.1111/bjd.15067

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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. 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.",

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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.

PY - 2017/7/1

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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.

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M3 - Review article

C2 - 27639072

AN - SCOPUS:85019723172

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EP - 33

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 1

ER -

Biosimilars for psoriasis: clinical studies to determine similarity

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ASJC Scopus subject areas

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