Introduction

The US is the largest and highest priced market for pharmaceuticals anywhere in the world. It therefore represents a very tempting target for companies wanting to launch copies of the very high-priced biological products with their multi-billion dollar turnovers.

The aim of this webinar is to provide some insight for non-regulatory people into the US regulatory procedure for registration of the biosimilar copies of these money-spinners.

It puts the US procedures into a geographical and historical context, with comparisons to the EMA, how the FDA is now playing catch up, and who have been the winners and losers so far.

It also examines the very important issues of Interchangeability, substitution and switching. What are they and how do they differ?

Lastly, we look at the confusing, but important, procedure known as "The Patent Dance" 

Area Covered In The Webinar

  • Overview - Biosimilars? Biogenerics? Follow-on Biologicals? What are we actually talking about?
  • Summary of issues affecting Biosimilars (Regulatory, Legal / IP, Commercial)
  • Interchangeability - what is the issue?
  • The regulatory process and its pitfalls 
  • Europe - the pioneers
  • The USA – catching up fast
  • Biosimilar registrations – successes and failures
  • The "Patent Dance" – what is it?

Why should you attend?

Upon completion of this workshop, attendees should have:

  • Understanding of the history - how EMA led the way and how FDA is catching up
  • Insight into the varying regulatory approaches prevailing in different regions
  • A good overview of the Biosimilars picture across the world
  • An overview of the barriers to entry
  • An understanding of the legal barrier known as "The Patent Dance"
  • Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company

Who Will Benefit

Anybody wanting to obtain an overview and basic understanding of the issues involved in registering biosimilars in the US with an overview of how these differ from European regulation.

ENROLLMENT OPTIONS

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Peter Wittner, B.Sc., is an independent consultant, speaker, and trainer specializing in the commercial aspects of generics with more than 35 years’ pharmaceutical experience. Before starting his own Know More

Peter Wittner