In a widely cited article, DiMasi, Hansen, and Grabowski (2003) estimate the average pre-tax cost of bringing a new molecular entity to market. Their base case estimate, excluding post‐marketing studies, was $802 million (in $US 2000). Strikingly, almost half of this cost (or $399 million) is...

In September 2015, the first biosimilar drug, Zarxio, was launched on the U.S. market. While the impact of generic entry on the small molecule branded market in the U.S. is well-understood, the impact of biosimilar entry on the large molecule biologic market has only been studied in Europe and...

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical...