Celltrion said it has completed a marketing authorization application for CT-P43, a biosimilar referencing Stelara (ustekinumab) that treats autoimmune diseases, to Australia’s Therapeutic Goods Administration (TGA) on Thursday (local time).

Celltrion filed a marketing authorization application in Australia for CT-P43 for the full range of indications covered by the original Stelara, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

The company previously applied for CT-P43 approval with the U.S.FDA, the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety.

Celltrion has been expanding its presence in the Oceania market since 2015 with the approval of Remsima for autoimmune diseases in Australia, followed by other products, including Herzuma for breast and gastric cancer, Truxima for hematologic malignancies, and Yuflyma for autoimmune diseases.

The completion of CT-P43 approval is expected to expand its presence in the market further.

Australia is one of the countries that have adopted a biosimilar-friendly policy, encouraging the prescribing of biosimilars since 2018 to reduce healthcare costs and increase patient access to biopharmaceutical treatments.

CT-P43's original drug, Stelara, is an interleukin (IL)-12 and 23 inhibitors developed by Janssen to treat autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a blockbuster product with a global market size of $17.7 billion (23.27 trillion won) in 2022, according to IQVIA, a global pharmaceutical market research organization.

"We confirmed CT-P43’s equivalence and similarity to the original drug in the global phase 3 clinical trial and completed its application to the Australian Therapeutic Goods Administration," a Celltrion official said. "We will continue to work with the regulatory authorities to ensure that the remaining approval processes are completed smoothly so that patients can benefit from the high-quality biopharmaceutical product at affordable prices."