Celltrion announced on the 3rd that it has submitted an application for the approval of its Stelara (ustekinumab) biosimilar to the U.S. Food and Drug Administration (FDA).

Its indications are the same as its original - plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, pediatric psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Celltrion conducted a Phase 3 clinical trial of Stelara biosimilar under the development name "CT-P43." The study evaluated the efficacy and safety of CT-P43 compared to Stelara, in 309 patients with moderate to severe plaque psoriasis aged 18 and older.

According to the Phase III clinical trial results that were announc