Policies & Legislation
Teva wants new rules for first generic entrants in EU
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Posted 06/07/2009
In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”
Regulatory approval of biosimilars in Europe
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Posted 06/07/2009
Biosimilars present a new set of challenges for regulatory authorities compared with conventional small-molecule generics, for which the demonstration of pharmacokinetic similarity to the reference product is sufficient.
