Gillian Woollett, MA, DPhil, senior vice president of Avalere, discusses policy and biosimilars in the United States.
Transcript:
Are there policy changes that would make the United States a better market for biosimilars?
Definitely we need policy changes, but how quickly we can implement what needs legislation, what needs regulations…all of those are delays, so I think what it comes down to is people understanding better what biosimilars offer; that as an economic matter they are essentially generics, and realizing because they’re approved by the FDA they are of the same quality and will have the same clinical outcomes as their reference. There are questions being raised that make it very, very difficult for biosimilars to penetrate. Plus, it takes a significant investment—about $500 million, a hundred times a generic—to get them to market. So, there needs to be a return on investment and yet, they’re being treated like brands, expected to be cheaper but costing more to produce. And so it’s a serious uphill battle.
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 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.