Craig Burton is the senior vice president of policy and strategic alliances at the Association for Accessible Medicines. He is also the executive director of the Biosimilars Council. In his current role, Craig is responsible for leading policy development and issues management for AAM, directing the Biosimilars Council, and building relationships with strategic partners in the health care sector, including patient advocacy groups.

Craig served as deputy assistant secretary for legislation in the US Department of Health and Human Services. In this role, he advised the Secretary, senior Department leaders and White House officials on legislative strategy to achieve key priorities. Craig also served in the Senate, where he was health policy advisor to Senate Majority Leader Bill Frist, MD, and as professional staff on the US Senate Committee on Health, Education, Labor and Pensions.

Giuseppe Randazzo is Senior Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines. Prior to joining AAM, Giuseppe worked on Novartis’ regulatory affairs team, where he collaborated in multiple regulatory policy arenas including drug and policy development, UFA negotiations, and trade association relations. Before Novartis, Giuseppe spent nearly 15 years at the Food and Drug Administration (FDA), where he was most recently an Office Director leading a team of 220 employees under the FDA’s Center for Drug Evaluation and Research. During his time at FDA, Giuseppe also worked in the Office of New Drugs, the Office of Compliance, and helped stand up the Office of Product Quality in coordination with the Office of Generic Drugs.

Giuseppe holds a B.A. in Chemistry and Physical Science Education from The Pennsylvania State University and an M.S. in Regulatory Science from The Johns Hopkins University.

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

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.

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.

 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. 

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

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To 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."

Escaping the Void: All Things Biosimilars With Craig & G

Introduction