US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

 
• By Derrick Gingery

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.

New fact patterns forced the FDA to restart first interchangeable biosimilar exclusivity guidance development. (Shutterstock)

More from Regulation

More from Products