Betting on biogenerics

摘要

The size of the small-molecule generic market runs into billions of dollars, and pharmaceutical companies go to great lengths to protect patents near the end of their lives. Although biologic patent expiries offer similar revenue opportunities, this is a totally different marketplace. Sales of the five major classes of therapeutic proteins (biologies) exceeded US dollar22 billion in 2002 (FIG l), a total that could rise to US dollar42.7 billion by 2007 (ref. l), despite the forthcoming patent expiry on a number of key products (including erythropoietin). Although patent expiry might normally signal an influx of generic competition, there are a number of hurdles to overcome before biogenerics can be successfully commercialized.