PPT-Biosimilars in the united states – Update on FDA Impleme

James C Shehan Hyman Phelps amp McNamara PC 700 Thirteenth Street NW Suite 1200 Washington DC 20005 USA 2027379634 jshehanhpmcom October 29 2014 Agenda BPCIA

fda product biosimilar reference product fda reference biosimilar exclusivity biosimilars bpcia substitution biological interchangeable products drugs biologics interchangeability 351

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