Celltrion, under the leadership of CEO Woo Sung Kee, announced on August 31st that it has successfully submitted a product approval application to the Therapeutic Goods Administration (TGA) in Australia for its biosimilar product 'CT-P43,' marketed under the brand name 'Truxima' (active ingredient: Ustekinumab).

The application submitted by Celltrion seeks approval for CT-P43 in Australia for all indications covered by the original drug, Stelara, which includes the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Previously, Celltrion had also completed product approval applications for CT-P43 with the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the South Korean Ministry of Food and Drug Safety (MFDS).

According to the company, Celltrion has been steadily expanding its presence in the Oceania market since 2015, starting with the approval of autoimmune disease treatments like 'Remsima,' followed by key products such as 'Herceptin' for breast and stomach cancer, 'Truxima' for blood cancer, and 'Yuflyma' for autoimmune diseases. With the completion of CT-P43 approval, the company anticipates that its influence in the market will further expand.

The original drug for CT-P43, Stelara, is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen. According to IQVIA, the global ustekinumab (the active ingredient in Stelara) market size in 2022 was approximately $17.713 billion (around 23.269 trillion Korean won), making Stelara a global blockbuster product.

A representative from Celltrion stated, "CT-P43 has demonstrated equivalence and similarity to the original drug in global phase 3 clinical trials, and we have completed the approval application with the Therapeutic Goods Administration (TGA) in Australia. We are committed to collaborating closely with regulatory authorities to facilitate the remaining approval processes, ensuring that patients can access high-quality biosimilars at affordable prices."