Celltrion Completes European Approval Application for Stelara Biosimilar 'CT-P43'

Original Full Indication EMA Marketing Authorization Application
"Sequential Approval Applications to Major Global Countries Planned"

Celltrion announced on the 26th that it completed the marketing authorization application for the autoimmune disease treatment biosimilar 'CT-P43' of 'Stelara (active ingredient ustekinumab)' to the European Medicines Agency (EMA) on the 25th (local time).

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

Celltrion confirmed similar efficacy, pharmacokinetics, and safety results to the original drug in the global Phase 3 clinical trial of CT-P43 conducted on 509 patients with plaque psoriasis in four countries: Korea, Poland, Ukraine, and Estonia. Based on these clinical results, Celltrion has completed the authorization application to the EMA for the full label indications of the original drug, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, and plans to sequentially apply for approval in major global countries.

The original drug of CT-P43, Stelara, developed by Janssen, is an interleukin (IL)-12 and 23 inhibitor used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to IQVIA, a global pharmaceutical market research firm, the global ustekinumab market size reached $17.77 billion (approximately 23.101 trillion KRW) last year. The substance patent for Stelara is set to expire in the United States in September this year and in Europe in July 2024.

Once Celltrion obtains EMA marketing authorization for CT-P43 and begins full-scale commercialization, it will secure autoimmune treatment products with interleukin inhibitors in addition to the Remsima product line, including Remsima IV, Remsima SC, and existing TNF-α (tumor necrosis factor) inhibitor products such as Yuflyma.

A Celltrion official stated, "Once CT-P43 obtains European approval, competitiveness in the autoimmune disease treatment area will be further strengthened alongside Remsima, Remsima SC, and Yuflyma, which have already entered the global market. We will do our best to proceed smoothly with the remaining approval procedures through consultations with regulatory authorities to introduce high-quality biopharmaceuticals to more patients."

Meanwhile, Celltrion is accelerating the securing of a follow-up portfolio in the autoimmune disease field, including CT-P47 (Actemra biosimilar) and CT-P53 (Ocrevus biosimilar), in addition to the Remsima line, Yuflyma, and CT-P43.

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