Pathway for Biosimilars Act gives agencies 'flexibility'

Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) have introduced legislation that would create a regulatory pathway for the FDA to approve follow-on or generic biologics. Their “Pathway for Biosimilars Act” would give the agency “flexibility” to determine the level of clinical testing needed and allow innovators 12 years of data exclusivity.