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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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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DOI: https://doi.org/10.1038/nbt0110-28
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