This article discusses innovative approaches to expediting biosimilar drug development. As sponsors of biosimilars seek additional efficiencies to get to the market more quickly, it behooves regulatory professionals to become aware of the different tactics and options that biosimilar drug developers can employ to bring copies of expensive biologics to the global market not only more quickly, but more broadly and less expensively. Introduction The biosimilars market cont...

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars. Introduction Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. For e...