Paragraph IV Disputes Master Symposium

The symposium, designed to serve the legal and business needs of both branded and generic drug makers, will examine the Hatch-Waxman litigation landscape. Topics will include a review of the current statutory framework, new bills under consideration, and Food and Drug Administration and Federal Trade Commission regulatory issues resulting from the Act.

In her workshop, titled “Working Group on Biosimilars for the Hatch-Waxman Litigator,” Deborah will provide an overview of biologic drugs and biosimilars, the approval process, and other key points of regulation, and an analysis of biosimilar case law. She will also use her experience in helping to build out the biosimilar framework at a global biotech company and her knowledge of the Hatch-Waxman regulatory trajectory to discuss the future of biosimilar product development in the United States.