February 1, 2015

Health Affairs — The Hatch-Waxman Act, a 1984 U.S. federal law, was introduced to promote the adoption of generic medications and help contain the cost of small-molecule drugs. Years later, the Biologics Price Competition and Innovation Act of 2009, enacted as part of the Affordable Care Act, created a streamlined FDA approval pathway for biosimilars, follow-on versions of biologics, with the goal of encouraging competition and controlling costs in the rapidly expanding biologics market. A new commentary compares the two Acts and examines the utilization management tools that are likely to be most successful in promoting adoption of biosimilars.