[Edaily Reporter KIM SAE-MI ] Celltrion ( Celltrion(068270)) announced on the 12th that it has submitted a marketing authorization application to the Australian Therapeutic Goods Administration (TGA) for “Visequma” (development code CT-P55), a biosimilar of the autoimmune disease treatment “Cosentyx.”

This marketing authorization application covers all indications held by the originator drug in Australia, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.

Previously, Celltrion confirmed the pharmacokinetic (PK) equivalence between Visequma and the originator drug in a clinical trial involving 172 healthy adults. It also secured similar results in terms of safety and immunogenicity.

Celltrion submitted marketing authorization applications for Viseuma starting in Canada last May, followed by South Korea in June, and the U.S. and Europe in July. With this application in Australia, the company has expanded its approval process to Oceania, following North America, Europe, and Asia.

Visequma is a biosimilar of Cosentyx, an interleukin (IL)-17A inhibitor. Cosentyx, developed by Novartis as a treatment for autoimmune diseases, recorded global sales of approximately $6.668 billion (about 9.3 trillion won) last year.

Celltrion plans to expand its existing portfolio of autoimmune disease treatments with Visequima. The company currently markets products such as “Remsima,” “Remsima SC” (U.S. product name: Zimpentra), “Uplima,” “Stekima,” and “Aptosima,” and once Visequima is commercialized, it will also enter the IL-17A inhibitor market.

Australia, in particular, is a market where Celltrion has established a business foundation by selling its existing autoimmune disease treatments. The company plans to leverage its local sales experience and distribution network to drive Visequima’s market entry.

A Celltrion spokesperson stated, “Visequima is accelerating its global expansion by filing for marketing authorization in Australia, following the U.S., Europe, and South Korea,” adding, “We will continue to expand the regions where we file for approval to strengthen the growth momentum of our biosimilar business.”

Meanwhile, Celltrion plans to expand its portfolio of biosimilars from the current 11 to 18 by 2030. In the autoimmune disease sector, the company is developing “CT-P53,” a biosimilar of Ocrebus, and “CT-P52,” a biosimilar of Talz. In the oncology sector, it is also advancing the development of “CT-P51,” a biosimilar of Keytruda, and “CT-P44,” a biosimilar of Dazalex.