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.
At issue is an agency requirement that a biosimilar medicine must be the same strength as the brand-name biologic treatment. A biosimilar is a nearly identical variant of a brand-name biologic treatment that yields the same health outcome, but at a lower cost. Anticipation over lower prices has fueled demand for biosimilars, prompting several large pharmaceutical companies to target this market.