World Biosimilar Congress

Topics:

Market access strategies, opportunities and commercial challenges

• Pricing and reimbursement
• Successful case studies from benchtop to market
• Ensuring clinical adoption

*New* Global clinical trials

• Designing clinical models and data use

Biosimilar development in emerging markets

• Global case studies

IP and legal considerations for biosimilars

• Obtaining patent protection while operating in an “anti-patent” climate

Biosimilar Development & Manufacturing

• Process development and plant design for biosimilars
• The latest on demonstrating interchangeability

Analytics, Development & Pharmacovigilance

• Analytical methods
• Sample processing
• Formulation

Updates on biosimilar regulatory guidelines

• Streamlining approval and access for follow-on biologics in Europe and USA
• CMC strategy