Biosimilars for psoriasis: Preclinical analytical assessment to determine similarity

Andrew Blauvelt, A. D. Cohen, L. Puig, R. Vender, J. Van Der Walt, J. J. Wu

    Research output: Contribution to journalReview articlepeer-review

    30 Scopus citations

    Abstract

    Biosimilars, sometimes called 'generic biologics', are no longer a vision for the future but a present-day reality. Drug manufacturers and regulatory authorities are charged with ensuring that these products are safe and effective. Because biologically produced medications are large, complex proteins, many factors affect the quality of the end product, including glycosylation and presence of impurities, and thus many factors need to be compared between an emerging biosimilar and its originator biologic. Indeed, preclinical analytical assessments to determine similarity to an originator biologic are critical and are considered to be the foundation for regulatory approval of biosimilars. Here, the science behind the preclinical development of biosimilars is discussed by members of the International Psoriasis Council, and suggestions are put forth to try to ensure that future biosimilars are produced in a high quality and standardized manner.

    Original languageEnglish
    Pages (from-to)282-286
    Number of pages5
    JournalBritish Journal of Dermatology
    Volume174
    Issue number2
    DOIs
    StatePublished - 1 Feb 2016

    ASJC Scopus subject areas

    • Dermatology

    Fingerprint

    Dive into the research topics of 'Biosimilars for psoriasis: Preclinical analytical assessment to determine similarity'. Together they form a unique fingerprint.

    Cite this