Post-conference workshop, Friday 2 March 2012

Pre-conference workshop, Tuesday 28 February 2012 ›

Post-conference workshop, Friday 2 March 2012 ›

last modified: 07 March '12

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Development and commercialisation framework for biosimilars

This workshop will examine the challenges to be addressed and identify strategies to enter this potentially lucrative market providing attendees with a picture of biosimilars across the world, insight into the varying regulatory frame work and approaches, understanding of the commercial situation and a strategy to enter biosimilar market.

9am

Registration and coffee

9.25am

Introduction to workshop leader

Mr. Peter Wittner

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...

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› Mr. Peter Wittner, Consultant, Interpharm Consultancy

9.30am

Regulatory aspects

• Overview - Biosimilars? Biogenerics? Follow-on Biologicals?
• Summary of issues affecting Biosimilars
• Interchangeability - what is the issue?
• The regulatory process and its pitfalls
• EMEA guidelines overview of successful and failed applications
• The USA - how will the new legislation work out?
• Japan - how it compares to EU / US
• Situation in other parts of the world

11am

Morning tea

11.30am

Commercial aspects - the story so far

• Biosimilars - the commercial reality
• Patents, IP and other issues
• The potential market - how big might it be?
• The story so far - EU/US/Japan
• Developing markets

1pm

Lunch

2pm

The future

• Who will be the winners - BigPharma or low cost manufacturers?
• Why make similar when you can make better?
• MAbs - can anyone afford to develop copies?
• EMEA guidelines / consultation November 2010
• Two-way split – Regulated vs unregulated

3pm