Samsung Bioepis strikes deal for Stelara biosimilar, but launch likely won’t come in time for an IRA exemption

Sam­sung Bioepis reached a deal this week that would al­low its Ste­lara biosim­i­lar hope­ful to launch in Feb­ru­ary 2025, adding to mount­ing com­pe­ti­tion against John­son & John­son’s an­ti-in­flam­ma­to­ry block­buster.

How­ev­er, it’s un­like­ly the can­di­date — or oth­ers un­der launch set­tle­ments with J&J — will amount to “mean­ing­ful com­pe­ti­tion” that would ex­empt Ste­lara from Medicare price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act.

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