The promise of biosimilars has captured the attention of the medical community. These drugs are described as the next wave in medicine, promising new treatments to help more Americans cope with serious diseases. But the nature of biosimilars complicates their path to market. As complex large molecule drugs, biosimilars are subject to a relatively new statutory regime, presenting novel regulatory issues. And there are a growing number of biosimilar applications on the horizon.
The Atlantic gathered key stakeholders to examine the emerging world of biosimilars and their regulatory framework in the United States. How does the Food and Drug Administration implement the biosimilar approval pathway? Do biosimilar drugs require the same clinical trials as the biologics on which they are modeled? How will the process impact access and affordability, and what does it mean for innovation?
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- Wednesday, December 07
- 8:30 a.m.WelcomeEmily Akhtarzandi, Managing Director, AtlanticLIVE
Christine Simmon*, Executive Director, The Biosimilars Council; Senior Vice President, Policy and Strategy Alliances, Generic Pharmaceutical Association
- 8:40 a.m.In The Halls of CongressSenator Bill Cassidy (R-LA)
With Joie Chen, Journalist and Contributor, AtlanticLIVE
- 9:05 a.m.In The Halls of CongressRepresentative Gene Green (D-TX)
With Ross Andersen, Senior Editor, The Atlantic
- 9:30 a.m.The State of ApprovalHillel Cohen, Executive Director, Scientific Affairs, Sandoz
Kimberly Greco, Director of Global Regulatory and Research and Development Policy, Amgen
David Rosen, Partner, Foley and Lardner LLP
Robert Ratner, Chief Scientific and Medical Officer, American Diabetes Association
With Joie Chen
- 10:00 a.m.Closing ThoughtsEmily Akhtarzandi
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“The feeling of the nation must be quickened; the conscience of the nation must be roused; the propriety of the nation must be startled; the hypocrisy of the nation must be exposed; and its crimes against God and man must be proclaimed and denounced.” - Frederick Douglass