Will Thursday Be the End of Biosimilars?


It is expected that the Supreme Court will hand down its decision on Health Care Reform this Thursday.  As we discussed in a previous post, there is a real possibility that the Court will strike down the entire Affordable Care Act, which includes the BPCIA authorizing approval of biosimilars in the U.S.  What will happen if the Court wipes out the statute?  The BPCIA took years to get through Congress the first time — will it be any easier on the second go-round, especially given the highly polarized partisan atmosphere?  There are certainly many interested parties that would like to change various aspects of the legislation, most particularly the 12 year exclusivity period for the brand biological.  The Obama administration has stated in the past that it would like the exclusivity period reduced to seven years.  More practically, what will happen to the INDs that have already been filed for biosimilars?  One would imagine that companies that have invested heavily in biosimilar product development would have to seriously consider repurposing their research for full BLA approval, rather than wait for a new BPCIA.  Whether they wait or they repurpose, biosimilar developers will incur huge costs that will certainly affect affordability of these drugs when (or if) they become available.