The biogenerics industry is experiencing a painful adolescence. After taking off on the back of the biotech boom during the late 90s, it has since come down with a thud as costs and timelines rise beyond most firms' forecasts. Unlike the rest of the biotech sector, biogenerics firms can't yet point to a successful precedent, and regulatory and clinical risks remain considerable. So while the entrepreneurship and flexibility associated with traditional biotech can favor small, standalone firms, the opposite is true in biogenerics. Most of the (likely few) winners in this game will be those quietly developing biosimilar products within divisions of traditional generics players.
Forthcoming patent expiries on more than $20 billion worth of biologicals, including growth hormone (GH), erythropoetin (EPO) and the interferons,...