C5 is pleased to present its inaugural Global Legal and Regulatory Summit on Biosimilars. This exclusive European event has been specifically designed for In House IP Counsel and Directors, Strategists and Business Development Executives, as well as Regulatory Affairs Executives and attorneys operating within the biosimilars community.

Agenda and speakers list will be available soon. Stay up-to-date by signing up to receive email notifications.

Day 1  |  3rd December 2019

9:00 Co-Chair Opening Introduction
9:10 Anticipating the Potential Brexit Effect on the European Biosimilars Marketplace
10:00 The International Perspective: Analysing the Present State of Global Affairs for Biosimilars
11:00 Networking Morning Coffee Break
11:30 Biosimilars Regulation in Europe and the U.S.: Comparing and Contrasting the EMA and FDA Approval Processes
12:30 Networking Lunch
13:30 Understanding How Regulatory Exclusivities Impact Innovator and Biosimilar Developers
Part 1: Survey of Available Exclusivities
Part 2: Panel Debate: Innovator vs. Biosimilar
15:00 Networking Break
15:30 Analysing the Practical Outcome of the Biosimilar Tendering Process
16:15 Think Tank on the Maximisation of IP Regulatory Rights: Hypothetical Exercise with Audience Participation and Polling

 

Day 2  |  4th December 2019

9:00 Co-Chair Opening Remarks
9:10 Breaking into The U.S. Biosimilar Market: Naming, Labelling and Marketing Considerations
10:00 Competition and Compliance: A Guide for Innovators and Biosimilar Manufacturers to Avoid Anticompetitive Behaviours
11:00 Networking Break
11:30 Analysing Current SPC Landscape and The Effects of the Manufacturing Waiver on Biosimilar Drugs
12:30 Networking Lunch
13:30 Biosimilar Patent Litigation: Major Considerations for Success in Europe and the U.S
14:30 Networking Break
14:45 Biosimilar Patent Filing Strategies in Europe
15:30 Strategic Business Decision Making: Biosimilar vs. Biobetter