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Interchangeability, immunogenicity and biosimilars

For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.

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Correspondence to Hans C Ebbers.

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The authors declare no conflict of interest relevant to the subject matter or materials discussed in the manuscript. No funding was received for the preparation of this article. This study was performed in the context of the Escher project (T6-202), a project of the Dutch Top Institute Pharma. The division of Pharmacoepidemiology and Clinical Pharmacology, where H.C.E. is employed, has received unrestricted funding for pharmaco-epidemiological research from GlaxoSmithKline, the private-public funded Top Institute Pharma (http://www.tipharma.nl, includes co-funding from universities, government and industry), the Dutch Medicines Evaluation Board and the Dutch Ministry of Health. H.S. participated in meetings and publications sponsored by Amgen, Johnson & Johnson, Roche, Sandoz and Hospira. Part of his research is directly or indirectly sponsored by Roche, Amgen and Sandoz.

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Ebbers, H., Crow, S., Vulto, A. et al. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 30, 1186–1190 (2012). https://doi.org/10.1038/nbt.2438

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