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"Not So Different": What's Holding Back Biosimilars? It May Not Be Pay-for-Delay Deals
While pay-for-delay issues have been big news on Capitol Hill recently, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.
Those who follow the biosimilars space closely will be increasingly familiar with the term “pay-for-delay” as it’s used to describe patent litigation settlements between brand-name drug makers and competitors that involve compensating generic or biosimilar developers to keep their products off the market.
These kinds of settlements have been the object of increased congressional interest in recent months, but while pay-for-delay issues have been big news on Capitol Hill, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.
To read more about the Federal Trade Commission report referenced in this episode, click here. You can also read more from Aly and Wallace at The Center for Biosimilars®.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.
