Pharmaceutical Medicine

, Volume 32, Issue 2, pp 103–121 | Cite as

Immunogenicity Assessment of Biosimilars

  • Tiina Reinivuori
  • Pekka Kurki
  • Paul Chamberlain
Review Article


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.


Compliance with Ethical Standards


No funding was received for the preparation of this review.

Conflict of interest

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


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Finnish Medicines Agency FimeaFimeaFinland
  2. 2.University of HelsinkiHelsinkiFinland
  3. 3.NDA Advisory BoardNDA Advisory Services, LtdLeatherheadUK

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