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 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
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