In association with Interpharm Consultancy
Why should you attend this event?
By attending this Master Class, you will gain:
- A good overview of the Biosimilars picture across the world
- Insight into the varying regulatory approaches prevailing in different regions
- An understanding of the commercial situation as it is now and likely to develop in the future
- Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company
Where does the event take place?
This Master Class will take place in central London, UK
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What is this event about?
Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier, since it is widely thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins on commodity generics.
However, while lower regulatory barriers in less regulated markets have allowed a biosimilars market to take off, the higher regulatory barriers in Europe and issues of interchangeability have resulted in a limited number of product launches so far and slow progress for those that are already in the market. Across the Atlantic, the situation is changing with the long awaited legislation now in place to simplify biosimilars registration. How will the legislation actually work and is it what the generic industry was hoping for?
The aim of this workshop is to give participants a good overview of the whole topic of biosimilars while investigating in more depth those topics that merit it. The workshop will look at all these issues and take a look into what the future may bring.
Who is leading this event?
Masterclass agenda
Peter Wittner's experience and qualifications
Purpose and scope of the workshop
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 - a straight forward case
EMEA guidelines
Overview of successful and failed applications
The USA - How will the new legislation work out?
Comparison of proposals and final version
Probable shape of the new regulatory mechanism
Japan
How it compares to EU / US
Situation in other parts of the world
Less regulated markets
Biosimilars - The Commercial Reality
What is the big attraction?
Biologicals market and prospects
Potential Biosimilars market
What has happened so far?
Europe and the USA
Asian markets and Latin America
Patents, IP and other issues
What are the patent issues?
Interchangeability - a potential roadblock
Differing national legislation
Where do Biosimilars go from here?
Chairman’s Closing Remarks and Close of MasterClass
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