I posted a few days ago on Abbott's letter to the FDA urging it to reconsider its policy on reviewing biosimilars. Abbott argues that to approve any biosimilar that is challenging a reference product filed prior to the law's enactment in March 2010 will necessarily cause the FDA to use innovator company trade secrets in their analysis -- and thereby violate provisions in the 5th amendment. Provocative, yes?
If Abbott's argument is correct or at least has good chance of being found so in the federal courts, this would seem to completely undermine the intent in geting biosimilars approved, and certainly would hamer any positive healthcare budgetary effects (i.e. saving drug costs) that Congress may have been seeking in passing this legislation.
Read more here in today's Pharmalot blog.
Posted by Bruce Lehr May 1st 2012.