Celltrion Applies for FDA Approval of Stelara Biosimilar... Targeting 23 Trillion Won Market

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

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

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

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 a blockbuster product used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.77 billion (approximately 23 trillion KRW) last year. Stelara's substance patent is expected to expire in the U.S. in September and in Europe in July 2024.

If Celltrion commercializes CT-P43, it will secure autoimmune treatment products that inhibit interleukins in addition to its existing tumor necrosis factor (TNF)-α inhibitor product lines such as Remsima IV, Remsima SC, and Upaliima. Based on the results from a Phase 3 clinical trial involving 509 patients with plaque psoriasis conducted in four countries including Korea, Poland, Ukraine, and Estonia, Celltrion confirmed that CT-P43 showed similar efficacy, pharmacokinetics, and safety to the original drug, and has continued 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 biosimilars?Stelara and Xolair ('CT-P39' in Europe and Korea), and Eylea ('CT-P42' in the U.S.)?out of the five biosimilars targeted for approval within this year, which also include Prolia (CT-P41) and Actemra (CT-P47). The company aims to complete the applications for Prolia and Actemra after finishing Phase 3 clinical trials within this year.

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