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Immunogenicity Assessment of Biosimilars

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Abstract

Biosimilar versions of original therapeutic proteins and peptides are approved on the basis of an extensive demonstration of analytical similarity to the originator product, including in-vitro tests for function. Comparative clinical evaluation is also performed in the pre-authorisation phase to confirm that the analytical similarity has led to comparable safety and efficacy, including immunogenicity. This article reviews the regulatory standards applicable to the assessment of relative immunogenicity of biosimilar candidates for marketing authorisation in the European Union and USA. The most critical elements for the design of an effective product-specific strategy to exclude potential incremental immunogenicity are discussed, and case examples are presented to illustrate how data are assessed by regulatory authorities.

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Fig. 1
Fig. 2

Drawn from data reported in Kaur et al. [50]

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Authors and Affiliations

  1. Finnish Medicines Agency Fimea, Fimea, Finland

    Tiina Reinivuori

  2. University of Helsinki, Helsinki, Finland

    Pekka Kurki

  3. NDA Advisory Board, NDA Advisory Services, Ltd, Grove House, Guildford Road, Leatherhead, Surrey, KT22 9DF, UK

    Paul Chamberlain

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  1. Tiina Reinivuori
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Tiina Reinivuori, Pekka Kurki and Paul Chamberlain have no conflicts of interest directly relevant to the content of this article.

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Reinivuori, T., Kurki, P. & Chamberlain, P. Immunogenicity Assessment of Biosimilars. Pharm Med 32, 103–121 (2018). https://doi.org/10.1007/s40290-018-0231-0

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