ABSTRACT
Lawmakers and regulators in the United States have believed a free market with high competition will take care of quality and price; that is, quality increases and prices will eventually decrease to dominate market shares. In 2009, in anticipation of generic drug economic effectiveness, whether big or small, the US Congress passed the Biologics Price Competition and Innovation Act (BPCIA), a subtitle within the larger Patient Protection and Affordable Care Act (PPACA). In their efforts to decrease health-care-related drug costs, US lawmakers and regulators overlooked an important component: in order to receive Food and Drug Administration (FDA) approval, new medicine should excel in its therapeutic efficacy compared to the existing drug in the market. The chapter illustrates the strategies AbbVie has employed to fend off other competitors, even when competitors have received FDA approval. Biosimilars were authorized as part of the federal health-care overhaul to reduce spending on biotech drugs, much like generics have cut the costs of pills.
