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 journalReview articlepeer-review

    15 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 languageEnglish
    Pages (from-to)23-33
    Number of pages11
    JournalBritish Journal of Dermatology
    Volume177
    Issue number1
    DOIs
    StatePublished - 1 Jul 2017

    ASJC Scopus subject areas

    • Dermatology

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