Korea Biomedical Review reported that Celltrion has finalised an agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43, its biosimilar to Stelara®, in the US on 7 March 2025. Celltrion submitted its aBLA to the FDA in June 2023, and is seeking to obtain marketing authorisation in 2024.
This follows J&J’s ustekinumab settlements with Fresenius Kabi and Formycon (AG) (with a US licensed entry date no later than 15 April 2025), Alvotech and Teva (with a US licensed entry date no later than 21 February 2025), Amgen (with a licensed entry date no later than 1 January 2025) and with Samsung (for an unknown licensed entry date).
Celltrion filed its MAA with the EMA for CT-P43 in May 2023.