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Tuesday 19 and Wednesday 20 February 2008, Brussels, Belgium
Given the remarkably strong R&D pipeline in the area, a predicted half of all products on the global pharma market will be biologics by the year 2010. The value of biologics that will be off-patent within the next two years is estimated to be in the region of $18 billion and with an EU regulatory framework now in place, the stage is set for more players to enter and claim their share of this lucrative market.
However, many challenges remain. Establishing a reliable product development process, understanding the regulatory pathway to follow in order to obtain approval and marketing authorisation, proving comparability and marketing the finished product are all issues that need to be addressed when deciding whether to create a biosimilar.
Through in-depth case studies and interactive roundtable discussions, VIB events’ Biosimilars 2008 conference will provide a platform to discuss and debate the regulatory, analytical and technical hurdles involved in entering this new market.
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