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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®.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits
May 28th 2025Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
