US administration considers reduction to biologics data exclusivity

A range of articles reporting that the Obama administration in its 2012 budget plans is proposing to reduce the US healthcare costs by increasing the uptake of generic biosimilars. They propose two different routes (1)  to reduce the period of data exclusivity from 12 years to seven for biological therapies. This would enable generic biologics manufacturers access to information much earlier enabling them to get there generic versions onto the market quicker. (2) to prohibit pay- to- delay deals; generic manufacturers challenge patents of brand name biopharma and are then paid off to halt the challenges.

http://www.whitehouse.gov/sites/default/files/omb/budget/fy2012/ass... 

http://www.reuters.com/article/2011/02/14/usa-budget-healthcare-idU... 

http://www.reuters.com/article/2011/02/14/usa-budget-healthcare-idU...

http://www.pharmatimes.com/Article/11-02-15/PhRMA_blasts_Obama_over...

This is would have significant impact on research and development of biotech making it financially very challenging to recoup R&D costs particularly with the increasing costs and time to achieve regulatory approval. However, this is potentially good news for generics manufacturers. For many years the pharma industry has been facing significant challenges to find successful business models and a common theme has been expanding biologics as a potential growth area. If these ideas are turned into law, new growth could be threatened. This is certainly one to watch- especially as it may have implications in the way things are done in Europe.