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…
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