Tackling the Intersection of Regulatory and IP Law for Biosimilar Drugs

The European biosimilar market is expected to grow robustly in the next five years, as a number blockbuster biologic are scheduled to lose patent protection in Europe. This expiration of patents and other intellectual property rights will create huge opportunities for the entrance of biosimilar drugs.

This exclusive event will provide you with best practices and legal insights to help you create a wholistic strategy for maximising commercial potentials in the Biosimilar marketplace.

This Exclusive European event has been specifically designed for Legal Directors, Strategy and Product collaboration, Regulatory Affairs, Intellectual Property Attorneys, General Counsels operating within the biosimilar drug manufacture community.

Sign up and stay tuned for more exciting programme announcement and our incredible speaker line-up!

Key Themes for This Year’s Event:

  • International Policy: Analysing the Present State of Affairs for Biosimilars
  • Regulatory Examination: Comparing and Contrasting EMA vs. FDA Approval Processes in Europe and the U.S.
  • Discover How Regulatory Exclusivities Impact Innovator and Biosimilar Developers
  • Analysing Current SPC Landscape and The Effects of Manufacturing Waiver on Biosimilar Drugs
  • Breaking into The U.S. Biosimilar Market: Naming, Labelling and Marketing Considerations
  • Examining Innovative Strategies for Protecting Your Portfolio Against Breaching EU Competition Law
  • Biosimilar Patent Filing Strategy in Europe
  • Strategic Business Decision Making: Biosimilar vs. Biobetter

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 Summit on Biosimilars is a unique event specifically tailored to the legal community handling biosimilars. It is based on extensive research with in-house legal counsel navigating the regulatory landscape for the leading pharmaceutical companies, the lawyers advising them, and the patent attorneys conducting freedom to operate analysis and formulating patent defense strategies.

Register now and enjoy early bird savings!


ACI’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.
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Event Contacts

For information about the programme and speaking opportunities please contact:

Alistair Ren-Healey
speakeropportunity@C5-Online.com

For sponsorship opportunities please contact:

C5 Communications
sponsorinfo@c5-online.com

For marketing support and Media Partnership opportunities please contact:

Linda Lam
marketingEnquiry@c5-online.com

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