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Clinical comparability and European biosimilar regulations

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Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics.

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Figure 1: Western blot analysis of Copaxone and three follow-on products.

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Authors and Affiliations

  1. Huub Schellekens is in the Departments of Pharmaceutical Sciences and Innovation Studies, Utrecht University, Utrecht, The Netherlands.,

    Huub Schellekens

  2. Ellen Moors is in the Department of Innovation Studies Utrecht University, Utrecht, The Netherlands.,

    Ellen Moors

Authors
  1. Huub Schellekens
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  2. Ellen Moors
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Corresponding author

Correspondence to Huub Schellekens.

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Competing interests

H.S. has participated in meetings and publications sponsored by companies producing biosimilars and/or innovative therapeutic proteins. His research is sponsored by Roche, Organon-Schering Plough, Merck-Serono and Stryker Biotech.

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Schellekens, H., Moors, E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 28, 28–31 (2010). https://doi.org/10.1038/nbt0110-28

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