Celltrion Is Latest To Settle Over Stelara

Deal With J&J Over CT-P43 Ustekinumab Biosimilar Offers Another 2025 Entry Date

25 Aug 2023

Celltrion has become the latest biosimilars developer to announce a deal with J&J allowing it to launch a US ustekinumab biosimilar in early 2025. The Korean firm anticipates US FDA approval next year for its CT-P43 version.

Sprinter on starting blocks With 2025 text — Celltrion’s biosimilar is set to enter the market in 2025 • Source: Shutterstock

Celltrion has become the latest biosimilar ustekinumab sponsor to secure a date-certain launch for its rival to Stelara in the US, announcing a settlement with originator J&J that will allow the Korean firm to launch its CT-P43 version from 7 March 2025, assuming US Food and Drug Administration approval.

Earlier this year, the company indicated that it had filed its biosimilar with the FDA in June. (Also see "

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