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Biosimilar/Biogenerics: Review of Regulatory Pathway
Thursday, November 15
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-537-L04
In response to scientific advances in manufacturing technology and controls, development of more advanced analytic methodologies and the ability to characterize and understand biological products, and patent expirations of biotech products that amount to dozens of billions dollars in revenue, biogenerics or biosimilars or follow-on protein products, whatever they are named, have become an interesting and important topic to biopharmaceutical industry and public health in recent years. Scientific conferences and workshops, and congressional hearings were conducted to discuss relevant scientific and legal issues. The FDA is considering the circumstances in which review and approval of follow-on protein products may be appropriate. This roundtable session is intended to understand the regulatory issues and challenges involved in follow-on protein products from regulatory perspective, and explore the regulatory mechanisms, review standard, and approval pathways.
Moderators
Jim Li, Ph.D.
Wyeth Pharmaceuticals
Peifan J. Bai, Ph.D.
U.S. Food and Drug Administration
Scientific Considerations for a US Regulatory Pathway for Biosimilars
Ajaz Hussain, Ph.D.
Sandoz
Biosimilarity: A Set of Equations with Multiple Variables
Amer Jaber, Ph.D.
Serono International
What Factors Should Be Considered in Defining Protein Product Comparability/Similarity
Hong Zhao, Ph.D.
U.S. Food and Drug Administration