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Session 1: Keynote Address - State of the Industry
Session Chair(s)
Juliana Marguerite Reed, MS
Executive Director
The Biosimilars Forum, United States
In this session, speakers will provide an overview of the biosimilars industry in the US, the FDA biosimilars program current and future state (evolution) as well as an overview of the industry from an economic perspective. The session will include insights on how the industry is responding to the new Administration, as well as planning for the future. In addition, the FDA will provide their insights on what the Agency sees and plans for the future of biosimilar development and regulatory oversight. Finally, Murray Aitken from IQVIA will provide an insightful analysis of the current biosimilars market place, the opportunity for biosimilars in the US and the “biosimilars void” that needs to be addressed and solved for by the attendees of this important conference so that industry can continue to develop low cost biosimilars for the patients who need them.
Learning Objective : - Understand the current and future state of the US biosimilar industry
- Articulate the evolving perspectives of the FDA OTBB on the regulatory landscape for biosimilar development, review, and approval in the US
- Explore the US biosimilars market, identify the “biosimilars void,” and discuss necessary changes to address this gap and foster biosimilar development in the US
Speaker(s)
Current and Future Perspectives of the FDA Biosimilars Program
Representative Invited
FDA, United States
Current and Future US Biosimilars Market, and the “Biosimilars Void and What to do About it”
Murray Aitken, MBA
IQVIA Institute for Human Data Science, United States
Executive Director
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