Seoul, March 13
Celltrion, a major South Korean biopharmaceutical firm, on Thursday said it has launched its biosimilar product for Stelara, an autoimmune disease treatment, in the United States.

Celltrion launches autoimmune disease treatment in US Steqeyma, a treatment for plaque psoriasis, Crohn's disease, active psoriatic arthritis and ulcerative colitis, is Celltrion's seventh biosimilar product that has hit the US market, the company said, Yonhap news agency reported.

The US Food and Drug Administration (FDA) approved the biosimilar drug in both intravenous and subcutaneous formulations in December, it said.

Earlier this week, the company’s biosimilar for asthma and other chronic allergic diseases obtained approval from US FDA for sales.

The FDA granted approved Celltrion's Omlyclo, a biosimilar drug to Xolair, for treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria (CSU), Celltrion said.

The drug can also be used to treat immunoglobulin E (IgE)-mediated food allergy and chronic spontaneous urticaria (CSU), Yonhap reported.

The biosimilar was also granted interchangeability status, enabling it to be substituted for the reference product without intervention by the prescribing healthcare provider, the company added.

The global market for Xolair was estimated to have reached 6 trillion won ($4.1 billion), including 3.7 trillion won in the US, as of 2024.

The drugmaker has been making efforts to expand its presence in the US biosimilar market.

In recent months, it has obtained FDA approval for the US sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, as well as Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva.

The global market for Stelara is estimated at $10.36 billion, with the US accounting for two-thirds of global sales.

Celltrion aims to commercialise 22 biosimilar products in global markets by 2030.