Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court finding the law constitutional in a 5-4 decision last June. The general public has not concerned itself with most of the act, particularly its establishment of a regulatory pathway for biosimilar versions of biologic medicines. The act created the Biologics Price Competition and Innovation Act (BPCIA), thereby starting the multibillion-dollar, biosimilar drug market of tomorrow and enhancing our future health-care savings. Its creation is analogous to a 1984 law, which established our current generic drug market and is colloquially referred to as the Hatch-Waxman Act in reference to its eponymous, congressional sponsors. Unlike today's generic drugs, there are no generic drugs or biosimilar versions of biologic drugs.

The biosimilars market is expected to be $19.4 billion by 2014 with an astonishing compound annual growth rate of about 85 percent. That value provides a glimpse into the $100 billion in branded, biologic sales expected to lose patent protection by 2020. The increasing demand to reduce health-care costs created numerous opportunities in the global market and the BPCIA will increase the shares and profit margins of the few market players. While we witness the rare birth of a multibillion-dollar market, how will that differ from genetic drugs.

Originally published in Chicago Daily Law Bulletin on November 7, 2012.