Celltrion said Monday that it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for a phase 1 Investigational New Drug (IND) application for CT-P55, a Cosentyx (secukinumab) biosimilar for the treatment of psoriasis.

Developed by Novartis, Cosentyx is an interleukin (IL)-17A inhibitor indicated for treating psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis.

Cosentyx had global market sales of $4.8 billion last year, according to Novartis. Its patent is scheduled to expire in January 2029 in the U.S. and January 2030 in Europe.

CT-P55 is part of Celltrion's pipeline of novel autoimmune disease biosimilars. Celltrion will conduct a phase 1 clinical trial in 171 healthy Japanese adults to compare the pharmacokinetic (PK) equivalence of CT-P55 to Cosentyx. The clinical trial of CT-P55 marks Celltrion's second clinical trial, following its Stelara biosimilar, CT-P43, an IL-12 and IL-23 inhibitors.

Celltrion plans to expand its portfolio in autoimmune diseases from tumor necrosis factor-alpha (TNF-α) inhibitors to interleukin inhibitors to strengthen its market competitiveness.

Celltrion has products and pipelines in autoimmune diseases, including Zymfentra (also known as Remsima SC internationally), Yuflyma, Stelara biosimilar CT-P43, and Actemra biosimilar CT-P47.

A Celltrion official said the company is taking its first steps into IL-17A inhibitor development with a new biosimilar pipeline, CT-P55, entering clinical trials and continuing its efforts to expand its portfolio of autoimmune disease therapies.

"In addition to the six biologics we have on the market today, we will continue to advance the development and approval of five additional pipelines through 2025, as well as the development of one of our key pipelines, CT-P55, to build a strong product portfolio," a Celltrion official said.

Following CT-P55's phase 1 IND approval in Japan, Celltrion's stock price on Kospi rose by 4.17 percent to close at 177,200 won ($136.6) on Monday.