FDA/DIA Biosimilars Conference: Guidances, Science, and BsUFA

Venue: Washington Marriott Wardman Park

Location: Washington, DC, District of Columbia, United States

Event Date/Time: Sep 12, 2012 End Date/Time: Sep 13, 2012
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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

Featured Topics
Session Topics

Stepwise approach to demonstrating biosimilarity
Totality-of-the-evidence approach to be used by FDA to review applications for biosimilar products
Considerations for the analytical similarity assessments when designing a biosimilar development program
Considerations of the complexities of therapeutic protein products when designing a biosimilar development program, including manufacturing process considerations
General scientific principles in conducting comparative structural and functional analyses, animal testing, human PK and PD studies, clinical immunogenicity assessment, and clinical safety and effectiveness studies
Use of data derived from studies comparing a proposed US biosimilar product with a non-US-licensed product
Considerations for global biosimilar product development programs
Postmarketing safety monitoring considerations
BsUFA requirements and implementation
Lessons learned from clinical development programs—regulatory and industry perspectives
Path forward—regulatory and industry panelist discussion

Who Should Attend
Pharmaceutical Executives
Biomedical Product Developers
Regulatory Affairs Professionals
Clinical and Nonclinical Researchers
Biostatisticians and Data Managers