Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA 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.
