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The Pharmaceutical Medicine Year that Was

A View from San Diego, California, at the End of 2010

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Notes

  1. Dr John Jenkins was appointed to a new position within the FDA, Associate Director for Biosimilars, within the Office of New Drugs on 19 May 2010.[2,3] The Healthcare Reform Bill in the US clearly had the development of a streamlined biosimilars approval pathway as one legislative intent, but the lawyers have found the language to be ambiguous, including the possibility that a small difference in the manufacturing process could enable ‘evergreening’ of a biosimilar, so as to garner the 12-year exclusivity of an innovator biological drug.[4]

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Authors and Affiliations

  1. Skaggs SPPS, University of California, San Diego, CA, USA

    Anthony W. Fox (Consulting Editor, Pharmaceutical Medicine)

  2. EBD Consulting, 2032 Corte del Nogal #120, Carlsbad, CA, 92011, USA

    Anthony W. Fox (Consulting Editor, Pharmaceutical Medicine)

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  1. Anthony W. Fox
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Fox, A.W. The Pharmaceutical Medicine Year that Was. Pharm Med 24, 339–342 (2010). https://doi.org/10.1007/BF03256834

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