FDA/DIA Biosimilars Conference: Guidances, Science, and BsUFA
Conference - Washington, DC, USA
Demonstrating Biosimilarity and Understanding FDA’s Approach and Guidance
The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was enacted as part of the Affordable Care Act. This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as, the perspectives of other regulators. The FDA guidance will be discussed from the perspectives of regulators and industry.
To promote transparency and facilitate development programs for proposed biosimilar products, FDA released three draft guidances for industry on February 9, 2012:
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Completion and Innovation Act of 2009.
(Courtesy of http://www.diahome.org/en/Meetings-and-Training/)
Sep 12 2012 7:00AM - Sep 13 2012 4:15PM
Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA
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