The Single Bioequivalence Study's Impact on the Dossier Broker

Abstract

This paper identifies the major trends that will affect the future of the classic pharmaceutical dossier broker, among them: the possibility of the single bioequivalence (BE) study between the USA and the European Union providing for interchangeable final approved Abbreviated New Drug Applications with granted marketing authorisations; current dossier fee waivers; and, the forward integration of active pharmaceutical ingredient suppliers in Europe. This paper offers a look at the impact of these trends on brokers, and suggests several strategies to help business development professionals in the generic dossier broker industry (who read the Journal of Generic Medicines) in adjusting their careers, with the common objective to bring affordable medicines to those who need them.

Keywords

dossier broker business development generic medicines market size single BE study cost of goods

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