Session B1/L6 – A competitiveness boost: how to strengthen biosimilar medicine developers in Europe?

Session B2 – What are the trends for the use of Biosimilar Medicines in medical practice in Europe?

• Market trends and policy frameworks – impact of biosimilar competition
• Ongoing stakeholder communities’ information and education initiatives
• Experience and Real World Evidence as an integral part of policy making

Session B3 – Improving Access to modern therapies: What can we learn from gainsharing practices?

• Illustrative examples of gainsharing schemes from across Europe
• Solving the equation: when medical use of biosimilar medicines directly or indirectly benefits physicians or hospitals
• Best gainsharing practices

Session B4 – What is sustainability? – A multi-stakeholder approach to securing the future of healthcare systems

• Definition of healthcare sustainability
• Stakeholders’ role in healthcare sustainability
• Lookout and longer-term perspective: multi-stakeholder collaboration

Session B5 – Connecting the Dots? Towards International Regulatory Convergence

• Key international regulators from the European Union, the United States, South Korea and Brazil
• Extrapolation of indications, statistical analyses of analytical similarity data, immunogenicity evaluation
• Importance of PK/PD studies, statistics in Clinical Trials

Session B6 – Convergence between Regulatory science and Medical practice: closing the loop

• European regulators’ positions on interchangeability and public study results
• Sharing and communicating real world evidence and pharmacovigilance data
• Good practice to reduce the gap between regulatory science and medical practice

Session B7 – What are the Key New International Developments? Any Regulatory Questions? Ask the Regulators!

• High level summary of international regulatory developments affecting biosimilar applications
• Unique opportunity for the audience to address scientific and regulatory questions directly to the regulators