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

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

Celltrion Global Biotechnology Research Center
[Photo by Celltrion]

On the 3rd, Celltrion announced that it submitted a marketing authorization application for CT-P43 to the Australian Therapeutic Goods Administration (TGA) on the 31st. This application covers the full-label indications of the original drug Stelara, including Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Since May, Celltrion has consecutively applied for CT-P43 approval to the European Medicines Agency (EMA), Korea’s Ministry of Food and Drug Safety, the U.S. Food and Drug Administration (FDA), and Health Canada.

Stelara, the original drug of CT-P43, is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen (a subsidiary of Johnson & Johnson) and is a representative blockbuster product in the autoimmune disease treatment field. The patent for Stelara is expected to expire in the U.S. in September and in Europe in July 2024. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.713 billion (approximately 23.4113 trillion KRW) last year.

This high revenue is also why Stelara was included in the first round of drug price reduction negotiations under the Inflation Reduction Act (IRA) announced by the U.S. Department of Health and Human Services (DHHS) on the 29th (local time). Despite Medicare’s high expenditure ranking, Stelara has been classified as a biologic drug without a biosimilar launched for over 13 years. Therefore, the prompt launch of biosimilars is considered urgently needed.

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

If Celltrion commercializes CT-P43, it will secure an interleukin inhibitor autoimmune treatment product in addition to its existing tumor necrosis factor (TNF)-α inhibitor product lines such as 'Remsima IV', 'Remsima SC', and 'Yuflyma'. 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.

Regionally, Celltrion has been expanding its market presence in Oceania by consecutively obtaining approvals for key products such as Remsima, which started in Australia in 2015, as well as cancer drugs 'Herzuma', 'Truxima', and Yuflyma. Australia is particularly notable as one of the countries that has introduced biosimilar-friendly policies since 2018 to encourage biosimilar prescriptions to reduce medical costs and improve patient access to biopharmaceuticals, raising expectations further.

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

A Celltrion representative stated, “We confirmed equivalence and similarity to the original drug in the global Phase 3 clinical trial of CT-P43 and have completed the approval application to the Australian TGA. We will do our best to ensure that the remaining approval procedures proceed smoothly through consultations with regulatory authorities so that patients can benefit from high-quality biopharmaceuticals at reasonable prices.”

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