Celltrion's Cosentyx biosimilar gets nod for phase 1 study in Japan

Celltrion's corporate logo (Celltrion)

South Korean biosimilar giant Celltrion said Monday it has gained approval for a phase one clinical trial of CT-P55 from a Japanese regulatory authority.

CT-P55 is Celltrion's new biosimilar candidate referencing Novartis’ psoriasis treatment Cosentyx (Secukinumab).

Upon approval from the Tokyo-based Pharmaceuticals and Medical Devices Agency, Celltrion will conduct a phase one clinical study with a total of 171 Japanese adults to compare the pharmaceutical equivalence of CT-P55 to Cosentix.

Cosentyx, developed by Novartis, is an interleukin-17A inhibitor for the treatment of psoriatic arthritis, ankylosing spondylitis and moderate-to-severe plaque psoriasis.

According to Celltrion, Cosentyx had global market sales of approximately $4.78 billion last year. Its product patent is set to expire in January 2029 in the US and January 2030 in Europe.

Celltrion said the company plans to strengthen its market competitiveness by expanding its biologics portfolio, particularly for autoimmune diseases such as tumor necrosis factor alpha inhibitors and interleukin inhibitors.

“With our new biosimilar pipeline CT-P55, we have taken our first steps into interleukin-17A inhibitor development,” a Celltrion official said.

“We will also continue advancing the development and approval of five additional pipielines by 2025, as well as the development of CT-P55, one of our key pipelines, to build a strong product portfolio.”

Celltrion currently possesses various biologics and pipelines in autoimmune diseases, including Ramsima, Ramsima SC, Yuflyma, Stelara biosimilar and Actemra biosimilar.

By Hwang Joo-young(flylikekite@heraldcorp.com)