Cultivating a vibrant U.S. market for biosimilars: A conversation with FDA’s Scott Gottlieb

Biologics, drugs manufactured thorough the techniques of modern biotechnology, represent a large and growing share of the U.S. drug market and offer the promise of treating disease and conditions for which there is no other cure. But they are expensive to develop and produce and, in contrast to other types of drugs, no one can make a precisely identical generic to compete with the original maker. To help foster competition, Congress created a pathway for “biosimilars,” including products demonstrated to be interchangeable (though not identical) to the original. But competition from biosimilars has been slower to develop in the U.S. than in Europe and the savings from competition that does occur in the U.S. hasn’t always led to lower prices for patients or insurers.

On July 18, the USC-Brookings Schaeffer Initiative for Health Policy and the Hutchins Center on Fiscal & Monetary Policy at Brookings hosted Food & Drug Administration Commissioner Scott Gottlieb for a discussion of biosimilars, which have been a major focus of the FDA’s efforts to increase competition and choice for patients and the U.S. healthcare system. Following his presentation, Mr. Gottlieb was interviewed by David Wessel, director of the Hutchins Center, and took questions. Then a panel of experts responded to Mr. Gottlieb and discuss related issues in the pharmaceutical market. The event was webcast.