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The FDA Presents Biosimilars in the US

  • December 09, 2019
  • 2:00 PM – 3:00 PM ET
  • Online
about

Biosimilars are a new drug category and major opportunity for savings in healthcare with estimates ranging from $44B and upwards. Biosimilars should also increase patient access through lower costs due to competition. Being a new category means that education on what biosimilars are is critically needed among all stakeholders.  Additionally, all stakeholders must operationally prepare to take advantage of the new opportunity that biosimilars represent. That is not current state of affairs.

The FDA will educate the audience on what biosimilars are and the National Business Group on Health will talk about the opportunity they represent.

Attendees will learn:

  • What biosimilars are
  • The safety and effectiveness of biosimilars
  • The savings opportunity that biosimilars represent


Speaker


Sarah Yim, MD
Acting Director, Office of Therapeutic Biologics and Biosimilars
Food and Drug Administration

Sarah Yim, MD, is the acting Director of the Office of Therapeutic Biologics and Biosimilars, in CDER’s Office of New Drugs (OND), within the FDA. Prior to that, she spent 2 years as Director of the Division of Clinical Review in the Office of Generic Drugs, and 11 years in various roles in rheumatology drug review in OND. She received her undergraduate degree from Stanford University, her Doctor of Medicine degree from the Uniformed Services University of Health Sciences, and completed a postdoctoral fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at the National Institutes of Health.


Tiffany McCaslin
Senior Policy Analyst
National Business Group on Health

Tiffany McCaslin is the Senior Policy Analyst at the National Business Group on Health. With more than 17 years’ experience in health policy, she is part of the team responsible for developing and coordinating the Business Group’s position and strategy on federal legislative and regulatory issues.  While she works broadly on policy issues impacting health benefits for large employers, her primary areas of expertise are health system reforms in the area of affordable access to pharmaceuticals.