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. 2018 Nov 1;9(7):699–716.

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Copyright © 2018, Harborside Press

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Regulatory process for biosimilars. PD = pharmacodynamics; PK = pharmacokinetics. Information from European Medicines Agency (2014); US Food and Drug Administration (2015b); World Health Organization (2009).