The Future of the U.S. Biosimilars Market: Development, Education, and Utilization

Speakers

Emily Alexander, AbbVie, Inc. Jeff Allen, Friends of Cancer Research Lisa Bell, Coherus BioSciences Leah Christl, U.S. Food and Drug Administration Greg Daniel, Robert J. Margolis, MD, Center for Health Policy at Duke University Elaine Daniels, Pfizer Jeff Eichholz, Express Scripts Andrea Ferris, Lungevity Kevin Haynes, HealthCore LLC Mark McClellan, Robert J. Margolis, MD, Center for Health Policy at Duke University Robert Rifkin, The U.S. Oncology Network Kristen Santiago, Cancer Support Community Carlos Sattler, Sandoz Richard Schilsky, American Society of Clinical Oncology Kim Wright, Komen Advocate

PLEASE NOTE:  Change in Location
Ritz-Carlton
1150 22nd St NW
Washington, DC
Salon 1 & 2

Friends of Cancer Research and the Duke-Margolis Center for Health Policy will convene a half-day forum bringing together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers to tackle remaining uncertainty surrounding the future of the U.S. biosimilars market.

The 2009 Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated licensure pathway, 351(k), for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference originator product. Because biologics are far more complex than small molecule drugs, the regulatory requirements for biosimilars are significantly greater than those for generic drugs. FDA issued the Guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product in 2012, and in 2015 the FDA approved Zarxio, the first biosimilar product submitted via the 351(k) pathway. The FDA also released several additional Biosimilarity Guidances in 2015 addressing the scientific, quality, and clinical pharmacology data needed to demonstrate biosimilarity. Despite this progress, however, questions remain for the implementation of the biosimilar pathway in the US, particularly for the development of monoclonal antibody (mAb). Several important biosimilar mAb therapeutics for treatment of autoimmune disorders and cancer are already in development or approved in other regions.