Inflation Reduction Act May Curb Patent Practices That Forestall Market Entry Of Biosimilars

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Perhaps accelerating the timeline for biosimilar (and generic) market entry is what the IRA had in mind when it chose several long monopoly products for price negotiation

with Senate Majority Leader Charles Schumer and House Majority Whip James Clyburn in the State Dining Room of the White House. The $737 billion bill focuses on climate change, lower healthcare costs and creating clean energy jobs.

Notably, the same committee approved similar legislation last year, but it did not get a vote in either house of Congress. It’s unclear if the most recent proposed piece of legislation has a better chance.in the U.S. than in Europe, where there is less expansive use of patent laws. European authorities have also approved more than twice as many biosimilars–93 in total–as the U.S.

Consider, for example, the mega blockbuster therapeutic, Humira. Its primary patents expired in 2016, but because of secondary legal protections AbbVie was able toMeanwhile, throughout Europe reimbursement authorities strongly favor Humira-referenced biosimilars, which have already been on the market for more than five years and have garnered 75% or higher market shares in many jurisdictions.

 

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