HHS says Stelara may be deselected from Medicare negotiations, depending on biosimilar launch

John­son & John­son’s Ste­lara may not be on CMS’ Medicare ne­go­ti­a­tions list for long, HHS ac­knowl­edged in court doc­u­ments filed last week.

The first 10 drugs se­lect­ed by CMS un­der the In­fla­tion Re­duc­tion Act will be sub­ject to ne­go­ti­at­ed prices start­ing in 2026, as long as they have no “mean­ing­ful com­pe­ti­tion,” ac­cord­ing to the cur­rent guide­lines. While it’s un­clear ex­act­ly where that bar stands, HHS thinks it’s a dis­tinct pos­si­bil­i­ty for Ste­lara, which is ex­pect­ed to have a biosim­i­lar ri­val by 2025.

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