Author Archives: Jacqueline Wright Bonilla

The New US Biosimilar Legislation, One Year Later

    About a year ago, President Obama signed into law the highly publicized health care reform bill known as the Patient Protection and Affordable Care Act. This legislation included the new Biologics Price Competition and Innovation Act of 2009 (now a “biosimilar statute”). Before enactment of that biosimilar statute on 23 March 2010, no “abbreviated” regulatory approval system existed in the United States for biologics — unlike Europe, which has had a system since 2005, and unlike US generic…