A Supreme Court chill across biosim­i­lar 'skin­ny' la­bels could halt bil­lions in Medicare sav­ings

As gener­ic drug­mak­ers con­tin­ue to pe­ti­tion the US Supreme Court to pro­tect a long­stand­ing prece­dent that al­lows them to carve out and mar­ket cer­tain in­di­ca­tions for a patent­ed brand name drug — un­der what’s known as a “skin­ny” la­bel — new re­search al­so rais­es ques­tions about bil­lions in sav­ings lost from skin­ny biosim­i­lar la­bels if courts leave this path­way in lim­bo.

A JA­MA re­search let­ter pub­lished yes­ter­day notes that of 21 biosim­i­lars mar­ket­ed be­fore 2022, 13 (62%) were launched with a skin­ny la­bel. An­nu­al es­ti­mat­ed sav­ings from those skin­ny la­bels in­creased from $2 mil­lion in 2015 to $857 mil­lion in 2020 as more bi­o­log­ics ran in­to this biosim­i­lar com­pe­ti­tion.

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