Celltrion Applies for Approval of Stelara Biosimilar in US and Canada... Targeting 23 Trillion Won Market (Comprehensive)

Consecutive Approval Applications Following Europe and Korea
Global Market Worth 23 Trillion, North America 19 Trillion Scale

Celltrion has applied for marketing authorization for its autoimmune disease treatment 'Stelara (active ingredient ustekinumab)' biosimilar ‘CT-P43’ in the United States and Canada, following Europe and South Korea.

Incheon Songdo Celltrion Plant 2 Exterior View [Photo by Celltrion]

On the 3rd, Celltrion announced that it submitted the marketing authorization application for CT-P43 to the U.S. Food and Drug Administration (FDA) and Health Canada on the 30th of last month (local time). This application covers the full-label indications of the original drug Stelara, including Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Celltrion had previously applied for CT-P43 approval from the European Medicines Agency (EMA) in May and from the South Korean Ministry of Food and Drug Safety last month.

Stelara, the original drug of CT-P43, is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen (a subsidiary of Johnson & Johnson). It is a blockbuster product used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The substance patent for Stelara is expected to expire in September in the U.S. and in July 2024 in Europe.

According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.7 billion (approximately 23 trillion KRW) last year. Among this, the North American market, including the U.S. and Canada, accounted for about 80% of the total market, with $14.246 billion (approximately 18.7 trillion KRW).

If Celltrion commercializes CT-P43, it will secure not only the Remsima product line such as Remsima IV and Remsima SC, and existing tumor necrosis factor (TNF)-α inhibitor products like Yuflyma, but also interleukin inhibitor autoimmune treatment products. Based on the results from a Phase 3 clinical trial involving 509 plaque psoriasis patients conducted in four countries including South Korea, Poland, Ukraine, and Estonia, Celltrion confirmed that CT-P43 showed similar efficacy, pharmacokinetics, and safety to the original drug, and has been continuing to apply for approval from global regulatory agencies.

Janssen (a subsidiary of Johnson & Johnson)'s autoimmune disease treatment 'Stelara' (generic name 'Ustekinumab')

Currently, Celltrion has completed marketing authorization applications for three of the five biosimilars targeted for approval within this year: Stelara and Xolair ('CT-P39' in Europe and South Korea), and Eylea ('CT-P42' in the U.S.). For Prolia (CT-P41) and Actemra (CT-P47), the company aims to complete Phase 3 clinical trials and submit approval applications within this year.

A Celltrion official stated, “We are accelerating efforts to strengthen competitiveness in the autoimmune disease treatment market by sequentially submitting marketing authorization applications for CT-P43 in major global countries during the first half of this year. We will also expedite the remaining approval processes through consultations with regulatory authorities in each country to ensure that high-quality biopharmaceuticals are supplied to the global market as soon as possible.”

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