Biosimilar Name and Shame: Senators Call Out FDA Guidance Efforts

Republicans express deep concern about agency’s biosimilar naming and labeling process.

Congressional dissatisfaction with FDA’s approach to guidance development reached a boiling point April 30, with eight Republican senators stating that finalizing biosimilar guidance may have in fact have made the agency’s policy position less certain.

The letter follows a series of correspondence and hearings in which senators questioned how FDA was offering advice...