Amgen’s win for a Stelara interchangeable biosimilar prompts questions about ‘meaningful competition’ under IRA
The FDA approval of Amgen’s interchangeable Stelara biosimilar is raising broader questions about how potential competition could impact Medicare price negotiations for Johnson & Johnson’s blockbuster.
Stelara (ustekinumab) was first approved in 2009 and last year generated nearly $6.4 billion in US sales in a slate of inflammatory conditions, according to J&J. It also cost Medicare Part D $2.6 billion between June 2022 and May of this year, CMS said, putting it on the agency’s list of 10 drugs subject to price negotiations under the Inflation Reduction Act.
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