How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (also known as MMA, the Medicare Modernization Act) to require that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the Federal Trade Commission (FTC) and the Department of Justice (DOJ). In this article, published in Biosimilar Development, Limin Zheng summarizes the key provisions of the new law, discusses its limitations, and takes a look at FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and how similar analyses may be applied to biosimilar settlements.


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