Developing a Legislative Pathway for Biosimilars in the United States

Abstract

Biologies are one of the fastest growing, most important, and most expensive segments of the pharmaceutical industry. The high price of biologies in the United States is making these life-saving drugs unaffordable for many Americans and creating unsustainable burdens on purchasers. While the EU has created an abbreviated approval process for biosimilars, there is no explicit legislative pathway in the United States that would enable generic competition for biologics. The Promoting Innovation and Access to Life-Saving Medicine Act would provide such a generic pathway for biologics, using competition to lower drug prices. The bill provides an appropriate balance between access to affordable medicine and retaining incentives for innovation.