Friday, 14 May 2010

USA - How will the new regulation of biosimilars impact the US pharmaceutical market?

The US pharmaceutical market has opened the market to biosimilars. It remains to be seen what will happen in practice.

In March 2010, the House of Representatives passed H.R. 3590. This is the bill as previously passed by the Senate, with some House amendments. The President signed it into law on 23rd March. H.R. 3590 includes the biosimilar pathway provisions.

Now that the legislation has become law, attention will move to its operation in practice, and it will be interesting to see when it will be used first, and by whom. There are a number of areas to watch: data exclusivity, evergreening, interchangeability and patent resolution.

Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published May 2010)

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