Opinion: What does ‘bona fide competition’ actually mean in the biologics market?
A lot turns on what “bona fide competition” means.
On Aug. 29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026. The Inflation Reduction Act (IRA), passed in August 2022, gives Medicare pricing power over therapies that both cost Medicare lots of money and have by 2026 enjoyed market exclusivity for a certain number of years — nine for small-molecule drugs and 13 for biologics.
Analysts have rightly criticized the congressional decision to once again confer greater protection on biologics. Congress previously drew this dubious distinction in 2010, when the biosimilar pathway it set up via the Biologics Price Competition and Innovation Act (BPCIA) conferred 12 years of data exclusivity on originator biologics, seven more than is given to originator small molecules under the Hatch-Waxman Act.
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