The budget proposed by President George W. Bush on February 4, 2008 included a new authority to approve generic biologics. On February 7, 2008, John Dingell, House Energy and Commerce Committee Chairman, indicated that he was not yet satisfied with any of the legislative proposals put forward to date. In an interview for the Reuters Regulation Summit, he stated "nobody has told me yet that they have something that would really satisfy me. As to, first of all protecting the consumer and assuring that in fact this was identical with the way [the brand name biologic] worked in the body." Three areas which will have to be addressed in any proposal include the (i) market exclusivity to be afforded to the innovative biologics, (ii) the size of the studies necessary to obtain approval, and (iii) interchangeability.
For more information, please see:
FDA budget seeks biotech generics and user fees http://www.reuters.com/article/companyNewsAndPR/idUSN0455467720080204 and
Dingell seeks workable biogenerics path http://www.reuters.com/article/healthNews/idUSN0741476420080208