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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