Celltrion Submits Marketing Application For CT-P43, Biosimilar To Janssen’s Stelara® (Ustekinumab)

Sep 1, 2023

Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for approval of CT-P43, its biosimilar to Janssen’s Stelara® (ustekinumab).   Celltrion applied for approval of all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Celltrion submitted its aBLA for CT-P43 to the US FDA in June 2023 (and reached a settlement and licence agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43 in the US on 7 March 2025), and submitted its MAA to EMA in May 2023.

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