Change in Biosimilar Exclusivity Period Takes Industry by Surprise

The drug industry and stakeholders have been taken aback by a measure in President Barack Obama’s proposed fiscal 2012 budget that would lower the exclusivity period for generic biologics from 12 to seven years. The proposal, advocated by Obama during the healthcare overhaul process but ultimately dropped from the final bill, came as a surprise even to many on Capitol Hill, where sources involved in creating the biosimilars legislation told DID there was no advance notice from the White House that changes to the exclusivity period were still being considered.
Drug Industry Daily