Venue: The Fuqua School of Business, Duke University, 1 Towerview Drive, Durham, NC 27708-0120

 

Presentation

Follow-on Biologics: Economic and Policy Issues

Authors:

Presenter: Henry Grabowski (Duke University)

Discussant: David Ridley (Duke University)

Session: Pharmaceuticals

Room: RJR Auditorium

When: Monday 5:15 p.m. - 6:45 p.m.

Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. Two important issues involve how the market for follow-on biologics is like to evolve compared to generic chemical entities and how Congress will balance the incentives for innovation and price competition. This paper examines current evidence on these questions. It presents an analysis of IP issues involving patent and data exclusivity. A breakeven analysis is performed of investment returns in biopharmaceuticals using representative R&D cost and sales values. This provides support for a significant data exclusivity period for new biologics.