Escaping the Void: All Things Biosimilars With Craig & G

Co-hosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

This special vodcast series provided by The Center for Biosimilars^® was developed in partnership with the AAM and Biosimilars Council.

Introduction

By Ashley Henyan, MA, MFA, director of communications at AAM

Since the passing of the Biologics Price Competition and Innovation Act in 2010, the FDA has approved over 70 biosimilar medicines. Since their entry to market in 2015, biosimilars have generated $36 billion in savings for America's patients and the US health care system. Biosimilars have proven they can unlock access to safe, effective, and more affordable treatments. But unfortunately, a dangerous trend threatens to halt progress related to biosimilar uptake and patient access.

In February 2025, an analysis from the IQVIA Institute revealed a massive biosimilar void.¹ A staggering 90% of biologic drugs losing patent exclusivity over the next 10 years have no biosimilar competition in the pipeline. This data underscores a flawed system that limits patient access and negatively impacts the livelihood of millions of Americans.

However, when it comes to biosimilars, we have the tools to fix the problem. With the right focus, collaboration, and reforms, we can ensure biosimilars continue to bring value to patients, providers, and the broader health care system.

With thanks to The Center for Biosimilars, this podcast series explores the current biosimilars landscape, dives into urgent actions needed from policymakers and regulators, and offers real-world insights into what changes are needed now to ensure the sustainability of the industry.

References

1. Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars