Alexandra Valenti, JD: Regulatory Scrutiny and Biosimilar Settlements

Alexandra Valenti, JD, partner at Goodwin, discusses whether drug makers are given pause by the possibility of regulatory scrutiny of patent settlements. 
October 18, 2019


So, the [Federal Trade Commission, FTC] and the [Department of Justice, DOJ] did an analysis following both the [Medicare Modernization Act, MMA’s] enactment of the regulatory review provision as well as the Supreme Court’s decision in FTC v Actavis that held that “pay-for-delay” agreements can be subject to antitrust review.

So, FTC’s analysis showed that both of those things did result in a decrease in the number of potentially problematic settlement agreements, again in the small-molecule context, that were being submitted for review. So, in terms of whether this will affect biologics’ patent settlement agreements, I think we’ll have to see what comes of the enhanced regulatory scrutiny. And there is also an open question as to whether the reasoning of the Supreme Court’s decision in FTC v Actavis regarding the antitrust issue extends to biologics. And so, it’s kind of a wait and see, I think.


Click here to view Biosimilars CME Activities

Click here to view Biosimilars PTCE Activities

Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars® is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2020 Intellisphere, LLC. All Rights Reserved.