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 Biologies Price Competition and Innovation Act of2009 (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 biologies — unlike Europe, which has had a system since 2005, and unlike US generic drug approval under the Hatch-Waxman Act of 1984. Regarding a biologic product, applicants previously could pursue a nonabbreviated biologic license application (BLA) under the Public Health Service Act or a new drug application (NDA), a "§505(b)(2)" NDA, or an abbreviated new drug application (ANDA) (for approval of a generic drug) under the Food, Drug, and Cosmetic Act (FDC Act). The new statute created a pathway for Food and Drug Administration (FDA) approval of potentially "abbreviated" applications for biological products shown to be "biosimilar" to or "interchangeable" with reference products previously approved under a BLA.
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