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.
From the May 01, 2008 Issue of MM+M - Medical Marketing and Media
