FDA to Follow Europe’s Approach to “Biosimilars” - Similar But Not Equal
March 16, 2007
The FDA Commissioner told AP reporters that FDA would take the approach now taken by European regulators for nonpatented biologics, rather than treating them as the Agency does small molecule generics. For Andrew Bridges' report click here.
The FDA Commissioner told AP reporters that FDA would take the approach now taken by European regulators for nonpatented biologics, rather than treating them as the Agency does small molecule generics. For Andrew Bridges' report click here.