The Future of Biosimilars in the US: Legal, Regulatory, Scientific, Regulatory, Clinical and Payer I

Venue: Bethesda North Marriott Hotel & Conference Center

Location: North Bethesda, Maryland, United States

Event Date/Time: May 04, 2011 End Date/Time: May 05, 2011
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On March 23, 2010, the Biologics Price Competition and Innovation Act was enacted into law as part of U.S. healthcare reform, establishing an approval pathway for biosimilar biological productsin the US. This Act and the way it is implemented will have huge impact on the development and availability of biological medicines in the US, both from an intellectual property and market access perspective. Hear the perspectives of FDA, industry, lawyers, academics, clinicians, payers and patients on the introduction of biosimilars to the US, including the critical challenges and the current ideas of these stakeholders.

Some of the questions to be addressed include:
• What level of similarity and extent of physio-chemical and biological data will be required to demonstrate the follow-on protein to be “highly similar” to the innovator product and to qualify as a biosimilar?
• What is the value of non-clinical testing for the demonstration of “biosimilarity”?
• How extensive should clinical testing be?
• To what extent can one extrapolate findings from one population to other populations based on the originator’s data?
• What criteria must be fulfilled to achieve interchangeability status?
• How does exclusivity operate under the BPCIA? Is it market or data exclusivity?
• When can supplemental applications qualify for exclusivity?
• What are the implications for intellectual property protection and litigation?
• What labelling and nomenclature need to be applied to biosimilars?
• What will be the impact on patient access to expensive biological medicines and to what extent will patient choice become compromised or even severely limited?

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