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Follow-On Biologics: Economic, Innovation and Policy Reflections The Fuqua School of BusinessDuke University
Charles DiLiberti
“Commercial Opportunities and Challenges for Follow-on Biologics”
Presentation Overview
Commercial Opportunities & Savings
Benefits of Generic Competition
Increasing Significance of Biologic Products
High Cost of Brand Biologics
Significant Cost Savings Opportunity
Generic Competition
Market Size for Select Biologic Products
Perspective:Historical Growth in Substitution
Generic BiologicsOpportunity
Science & Technology Challenges
Scientific Challenges for Generic Biologics
Generic Biologics
Biologics Size Does Matter...
Misinformation Campaign About Generic Biologics
Generic Biologics (Biosimilars) in the EU
EU Biosimilar Approvals
FDA Approves Sandoz’s Omnitrope
Development of Generic Biologics
Development Considerations
Regulatory & Intellectual Property Issues
Challenges for Generic Biologics
Regulatory Issues
Abbreviated Generic Pathway Under PHSA
Existing Incentives for Brand Biotech Companies
Regulatory IssuesU.S. Proposed Legislation
Summary
Generic Biologics in US
Broad, Bipartisan Support for a Workable Pathway for Generic Biologics
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