Celltrion Applies for Approval of ‘STELARA’ Biosimilar in Australia

Celltrion Applies for Approval of Autoimmune Disease Treatment Biosimilar in Australia

The CEO of Celltrion, Ki Woo-seong, has submitted an application for approval of the biosimilar ‘CT-P43’, an item for the treatment of autoimmune diseases, to the Therapeutic Goods Administration (TGA) of Australia. The application, issued on the 31st, encompasses all indications of the originator drug ‘STELARA’, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

This move follows Celltrion’s previous applications for item approval of CT-P43 to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Food and Drug Safety Administration in Korea.

Celltrion has been making significant strides in the Australian market with their autoimmune disease treatments. Since 2015, their offerings of ‘Remsima’ for autoimmune disease treatment, ‘Herzuma’ for breast and stomach cancer treatment, ‘Truxima’ for haematological cancer treatment, and ‘Ulyma’ for autoimmune disease treatment have been successfully launched in the region. With the completion of the CT-P43 license, Celltrion expects their market influence to expand even further.

The original drug, Stelara, developed by Janssen, is an inhibitor of interleukin (IL)-12, 23. It holds a prominent position in the global market, with projected sales of $17.713 billion in 2022, according to IQVIA.

A Celltrion representative stated, “CT-P43 has demonstrated equivalence and similarity to the original drug in the global phase 3 clinical trial, leading to our application for approval from the Australian Food and Drug Administration (TGA). We are committed to ensuring a smooth approval process through constructive discussions with regulatory authorities.”

centrion(CEO Ki Woo-seong) has completed an application for approval of an item for autoimmune disease treatment ‘STELARA (ingredient name Ustekinumab)’ biosimilar ‘CT-P43’ to the Therapeutic Goods Administration (TGA) of Australia issued on the 31st .

Celltrion applied for item CT-P43 approval in Australia on the same day for all indications of the originator drug Stelara, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Celltrion has previously completed applications for item approval of CT-P43 to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Food and Drug Safety Administration in Korea.

According to the company, Celltrion has started ‘Remsima’, an autoimmune disease treatment, in Australia since 2015 △ Breast cancer / stomach cancer treatment ‘Herzuma’ △ Haematological cancer treatment ‘Truxima’ △ Autoimmune disease treatment ‘Ulyma’ is expanding its presence in the Oceania market by acquiring licenses for major products one after the other. The company predicted that once the CT-P43 license is completed, its influence in the market will expand further.

Stellara, the original CT-P43 drug JanssenIt is an inhibitor of interleukin (IL)-12, 23 developed by According to IQVIA, the global market for Ustekinumab in 2022 will be $ 17.713 billion (about 23.269 trillion won), and Stellar is a world blockbuster product – wide

centrion An official said, “CT-P43 confirmed the equivalence and similarity compared to the original drug in the global phase 3 clinical trial and completed the application for approval from the Australian Food and Drug Administration (TGA).” We will do our best to move forward with the rest of the approval process without a hitch through discussions with the regulatory authorities.”

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