BIOSIMILARS AFTER ACTAVIS: SIMILAR CONSIDERATIONS, SIMILAR RESULTS
Author: Jason M. Premus
On September 3, 2015, the United States watched as the first “generic-like” biologic drug entered the market ushering in a new era for the pharmaceutical industry. In tow, the hopes of the American people and the promise of lower-priced, life-altering medication. This entry comes at a time when the lower courts and the pharmaceutical industry are wrestling with the Supreme Court’s decision in FTC v. Actavis, which one commentator has called “one of the most important business cases in the past generation.” In Actavis, the U.S. Supreme Court held that “reverse payment settlements”—payments made by brand-name drug manufacturers to generic drug companies to delay entry—could sometimes fail to pass antitrust muster and are subject to “rule-of-reason” analysis. While Actavis and subsequent lower court cases have addressed reverse payment settlements in the context of generic small-molecule drugs and their respective statutory scheme, the Drug Price Competition and Patent Term Restoration Act (informally known as the Hatch-Waxman Act), a question that remains unanswered, is how the decision might apply to generic-like or follow-on biologic drugs and their respective statutory scheme.