STAT+: In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
Arguing the Food and Drug Administration is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to alter its interpretation of the word “strength” found in a federal law that has made it possible to sell these medicines.
The move reflects a wonky, behind-the-scenes dispute that, nonetheless, holds potentially great significance for the burgeoning growth of biosimilar treatments in the U.S., which is expected to reach $80 billion in aggregate sales over the next five years, according to one recent forecast.
