Many of the best-selling ‘blockbuster’ biological medicinal products are, or will soon be, facing competition from similar biological medicinal products (biosimilars) in the EU. Biosimilarity is based on the comparability concept, which has been used successfully for several decades to ensure close similarity of a biological product before and after a manufacturing change. Over the last 10 years, experience with biosimilars has shown that even complex biotechnology-derived proteins can be copied successfully. Most best-selling biologicals are used for chronic treatment. This has triggered intensive discussion on the interchangeability of a biosimilar with its reference product, with the main concern being immunogenicity. We explore the theoretical basis of the presumed risks of switching between a biosimilar and its reference product and the available data on switches. Our conclusion is that a switch between comparable versions of the same active substance approved in accordance with EU legislation is not expected to trigger or enhance immunogenicity. On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety or efficacy in individual patients upon a switch. Our conclusion is that biosimilars licensed in the EU are interchangeable.
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The authors thank Drs. Meenu Wadhwa and Christian Schneider for their valuable expert comments during the preparation of the manuscript. The generous help of Ms. Mira Juppi is also gratefully acknowledged.
PK conceptualized the idea for the study. The manuscript was written by PK, LvA, EW-H, TG, VS, and MW.
Conflict of interest
PK, LvA, EW-H, TG, VS, and MW have no conflicts of interest. They are employees of national regulatory agencies. However, the opinions expressed in this article represent the personal opinions of the authors.
No funding was received for the preparation of this manuscript.
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Kurki, P., van Aerts, L., Wolff-Holz, E. et al. Interchangeability of Biosimilars: A European Perspective. BioDrugs 31, 83–91 (2017). https://doi.org/10.1007/s40259-017-0210-0