Celltrion Presents Phase 3 Results of Stelara Biosimilar 'CT-P43' at European Conference

Autoimmune Disease Treatment Biosimilar
Global Phase 3 Results Presented at European Academy of Dermatology
Efficacy, Equivalence, Safety, and Similarity All Confirmed

Celltrion announced on the 12th that it presented the 52-week results of the global Phase 3 clinical trial of the biosimilar 'CT-P43' of the autoimmune disease treatment 'Stelara' (active ingredient ustekinumab) at the European Academy of Dermatology and Venereology (EADV) on the 11th (local time).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

The EADV is a prestigious European dermatology society, held simultaneously in Berlin, Germany, and online for four days from the 11th to the 14th of this month. Celltrion disclosed the 52-week results of the global Phase 3 clinical trial conducted on 509 patients with plaque psoriasis through a poster presentation at this conference.

Celltrion conducted the trial by dividing patients into the Stelara administration group and the CT-P43 administration group. From week 16 of administration, the Stelara group either switched to CT-P43 or continued Stelara administration, and results were analyzed up to week 52.

According to Celltrion, the analysis confirmed similarity in efficacy and safety between the Stelara and CT-P43 groups throughout the clinical period. Even after switching from Stelara to CT-P43 and monitoring up to week 52, efficacy was maintained similarly compared to the group that continued Stelara. Regarding safety, there was no significant difference in adverse reactions between the groups during the clinical period, and immunogenicity was also similar between the Stelara maintenance group and the CT-P43 switch group, confirming similarity in efficacy, safety, and immunogenicity for switching from Stelara to CT-P43.

This year, Celltrion has completed the approval applications for CT-P43 covering all indications held by Stelara, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, in major countries such as South Korea, the United States, Europe, Canada, and Australia. According to IQVIA, a global pharmaceutical market research firm, the global ustekinumab market size reached $17.713 billion (approximately 23.71 trillion KRW) last year.

In August, the patent agreement for CT-P43 in the United States with the developer of Stelara was also finalized. The U.S. market, considered the largest global market for ustekinumab, is valued at $13.628 billion (approximately 18.25 trillion KRW), accounting for about 77% of the total market. Celltrion expects that obtaining approval in the U.S. will place them in a favorable position to increase sales.

The original drug of CT-P43, Stelara, is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen, a subsidiary of Johnson & Johnson. It is used as a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

A Celltrion official stated, "CT-P43, for which approval applications have been completed in major global countries, revealed the Phase 3 clinical trial results at the prestigious European dermatology society, reaffirming its efficacy and safety compared to the original drug. We will do our best to proceed smoothly with the remaining approval processes for CT-P43, expand our portfolio with interleukin inhibitors in the global autoimmune disease treatment market, and solidify our leading position."

This content was produced with the assistance of AI translation services.