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Celltrion Is Latest To Settle Over Stelara

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

 
• By Dave Wallace

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 "Celltrion Files Stelara Biosimilar In US And Canada" - Generics Bulletin, 4 July, 2023.) The submission followed Phase III trials for the candidate that kicked off in late 2020

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