Biosimilars: Industry Challenges and Opportunities after the Public Hearing
November 09, 2010Biosimilars: Industry Challenges and Opportunities after the Public Hearing
12:00 PM ET
Webinar with interactive Q&A
New legislation, guidances to come, and a public meeting with the FDA to dissect.
FDA's public hearing on biosimilars will provide a forum for interested stakeholders to provide input regarding the agency's implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" (biosimilar) to, or "interchangeable" with, an FDA-licensed biological product concerning certain issues, among others. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act and in the development of related guidances and rulemaking.
Please join Elsevier Business Intelligence and PAREXEL Consulting for a thought-provoking 90 minute analysis of the hearings during this exclusive webinar. With a full 30 minutes of interactive Q&A.
Exclusive coverage analysis will offer:
- Overview of the status of biosimilars in the US: scientific, regulatory and market access perspective
- Key take-aways from the FDA public hearing on biosimilars
- Updates on the biggest biosimilar development challenges facing industry
- Predictions of FDA positions on key issues in biosimilar development
- Next steps for FDA and industry
Presenters:
Dr. Bruce Babbitt Principal Consultant
PAREXEL Consulting
Cecil Nick Vice President
PAREXEL Consulting
M. Nielsen Hobbs Editor, Elsevier Business Intelligence
"The Pink Sheet"
Charles A. Stevens, JD, MBA VP & General Manager, Reimbursement & Market Access
PAREXEL Consulting
Click on the event website to register.
For more information on our biosimilars expertise and services please click here.
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