This chapter describes the market for pharmaceuticals, which exceeded $500 million in sales in 2010. The industry is also characterized by extensive regulation of almost every activity, from product development through manufacturing and marketing, which we summarize. We next describe the...

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...