US Biosimilar Regulations, Barriers and FDA Expectations

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.

Areas 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

Who Will Benefit:

• Marketing department
• Business Development
• Strategic planners

Peter Wittner
Senior Consultant, Interpharm Consultancy

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial aspects of generics with more than 30 years’ pharmaceutical experience. Before starting his own business, Peter headed the European sales and marketing departments of the UK generics companies Evans Medical and H.N. Norton, which later became part of IVAX.

He later joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business and then returned to consultancy work. Interpharm advises new market entrants on generic strategies, assists in business development for generic companies based outside the EU that are trying to enter the market and works with companies that are seeking to enlarge their product range. While mainly oriented to the commercial side with services such as market intelligence and pricing overviews for example, Interpharm also advises on IP and patent issues as well as the legal background to the pharmaceutical industry in Europe and the US.

On the other side of the equation, Interpharm has also worked with originator companies that are looking at ways of defending their major brands from generic incursion.

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