Celltrion's Stelara biosimilar receives approval in Korea

A Celltrion researcher is holding a drug vial. (Celltrion)

South Korean biosimilar giant Celltrion announced Thursday that Steqeyma, the company’s biosimilar referencing Stelara, has been approved by the Ministry of Food and Drug Safety.

Stelara (ustekinumab) is Johnson & Johnson's blockbuster drug used to treat patients with plaque psoriasis. According to market research company IQVIA’s report, the global ustekinumab market was estimated to reach $20.3 billion as of last year.

Celltrion said Steqeyma has been approved for its uses in all indications of reference product Stelara, including psoriatic arthritis, Crohn's disease and ulcerative colitis.

Celltrion is now able to sell Steqeyma in the Korean market. But, when the drug will be launched domestically is not yet decided, according to the company.

With the latest approval, Celltrion has successfully added an interleukin inhibitor to the company’s biosimilar pipeline, which was limited to tumor necrosis factor-a inhibitors, such as Remsima SC and Yuflyma.

“Celltron has been able to expand its biosimilar portfolio with the domestic approval for Steqeyma. The company will continue its efforts to receive regulatory approvals in the major overseas markets,” an official from Celltrion said.

Celltrion is currently seeking US and European approvals for Steqeyma. Celltrion submitted its applications to the European Medicines Agency in May last year and to the US Food and Drug Administration in the following month.

“Celltrion is expected to receive greenlights for Steqeyma in the US and Europe as early as this year,” an industry source said on condition of anonymity.

Johnson & Johnson’s immunology drug Stelara lost its patent protection in the US in September last year. In Europe, Stelara will lose its patent protection in July.

“Celltrion has already reached settlement agreements with Johnson & Johnson for launching Steqeyma in 2023,” to speed up its US launch after clearing the regulatory process, the company noted.

By Shim Woo-hyun(ws@heraldcorp.com)