- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
"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®.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.
