Introduction

This webinar will discuss the history of biosimilar - how EMA led the way and how FDA is catching up. It will give Insight into the varying regulatory approaches prevailing in different regions & overview of the Biosimilars picture across the world, the barriers (known as "The Patent Dance") to entry. It will discuss about interchangeability issues, what proof does FDA require, US biosimilar registrations success and failures and how to avoid failures. Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company.

Area Covered In The Webinar

Overview – Biosimilars? Biogenerics? Follow-on Biologicals?

  • What are we actually talking about? Definitions
  • Summary of issues affecting Biosimilars
  • Regulatory – structural characterisation, pre-clinical and clinical data
  • Legal / IP – how patents affect registration
  • Commercial – what makes the market so interesting?

Interchangeability – what is the issue? What does it mean?

  • Definitions – interchangeability, substitution, switching

Some history

  • Europe – a straight forward case
  • First generation biosimilars – EPO, Filgrastim, HGH, LMWHeparins
  • Second generation – Monoclonals
  • The USA – why did it lag behind?

USA – What the legislation (Biologics Price Competition and Innovation Act of 2009) states

USA – how the FDA has translated law into guidelines

  • How is the new legislation working out?
  • Interchangeability – what proof does the FDA require?
  • EU vs US differences – the Enoxaparin example

The regulatory process and its pitfalls

  • What does the FDA want? Some detail
  • Preclinical
  • Non-clinical
  • Structural characterisation
  • Clinical
  • Post-marketing / pharmacovigilance
  • How to ensure that you comply – what is “Best Practice”?

US biosimilar registrations – successes and failures

  • Successes – approved registrations (compared to same molecules in EU)
  • Failed applications – what went wrong?
  • Failures and how to avoid them
  • What has happened in the market

The "Patent Dance" – what is it?

  • How to avoid problems

Why should you attend?

A large number of companies are looking for ways to enter the Biosimilars market, but first they have to overcome the regulatory barriers. Despite high regulatory barriers in Europe and issues of interchangeability there have been a number of successful product launches. Across the Atlantic, progress has been much slower but the situation is changing with the long awaited legislation and FDA guidelines now in place to simplify biosimilars registration. How is the legislation actually working out and is it what the generic industry was hoping for?

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 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, looks at the precedent set by the EMA, how the FDA is now playing catch up, and who have been the winners and losers so far, what FDA is asking for and how to avoid failures.

Who Will Benefit

  • Marketing department
  • Business Development
  • Strategic planners

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