Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace

The European Biosimilar Market is expected to grow robustly in the next five years. A significant number of blockbuster biologics are scheduled to lose patent protection before 2025, and as such will create huge opportunities for the entrance of biosimilar drugs across the continent.

In light of these developments, C5 is pleased to present its inaugural Global Legal and Regulatory Summit on Biosimilars. Join us as we track the latest legal and regulatory ramifications for biosimilar stakeholders. Be part of interactive discussions that will enable you to develop a wholistic legal and regulatory strategy for maximising commercial results for your biosimilar products.

Final Agenda and Speakers List Now Available!


Meet the Co-Chairs:

Lindsey Kent
Lindsey Kent
Assistant General Patent Counsel
Eli Lilly
Alexandra Moulson
Alexandra Moulson
Head Strategy, Portfolio and Program Management
PolPharma Biologics

Obtain Insights from Key Global Industry Stakeholders:

  • Abbott Laboratories
  • Alexion Pharma GmbH
  • Amgen
  • Biocon Research Limited
  • Fresenius Kabi
  • Formycon AG
  • Glenmark Pharmaceuticals
  • UCB Biopharma

Also featuring alumni of: Novartis | Teva | Sandoz

Government insights from Europe and the US:

German Patent and Trade Mark Office

U.S. Food and Drug Administration


Benefit from In-Depth Discussions which Will Help You:

  • Understand how international affairs are influencing the future of biosimilar development and commercialization
  • Analyse the business and legal repercussions of the EMA and FDA biosimilar approval processes
  • Comprehend the importance of regulatory exclusivities in biosimilar development from the perspectives of innovators and generics
  • Assess the effects of the current SPC landscape and manufacturing waiver on biosimilar patents
  • Navigate the complexities of U.S. market entry: naming, labeling, and marketing considerations
  • Evaluate the nuances of the Asian Biosimilars marketplace: Japan, Korea, China
  • Develop innovative strategies to prevent compliance breaches of EU competition law

Join us at this exciting time of change and planning your future biosimilar strategy! Register now and enjoy early bird savings

Who Needs to Attend:

Pharmaceutical and Biotech Companies:
  • Patent, Intellectual Property Attorney
  • Director of IP/Intellectual Property
  • Head of Legal
  • IP and Business Strategy
  • General Counsel
  • Regulatory Affairs
  • Regulatory Specialist
Private Practice Lawyers and Patent Attorneys specialising in:
  • Life Sciences

C5’s Global Series of Life Sciences conferences bring together key sector stakeholders from around the globe to explore the most important trends impacting the many industries including pharmaceutical, biotechnology, medical device/diagnostics, and FDA-regulated consumer products. Our events cover every facet of legal and business relevance as well as controversy. Learn More

Event Contacts

Programme and Speaking Opportunities
Alistair Ren-Healey
Email Us
Sponsorship Opportunities
C5 Communications
Email Us
Media Partnership Opportunities
Linda Lam
Email Us