World Biosimilar Congress Europe

World Biosimilar Congress Europe

 

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