Celltrion seeks approval for Stelara biosimilar in EU – The Investor

Celltrion's corporate logo (Celltrion)

Celltrion said Friday that the company has submitted a marketing authorization application for CT-P43, the company's ustekinumab biosimilar referencing Stelara, to the European Medicines Agency.

Stelara is one of Janssen's top-selling drugs. In 2022, Stelara generated $9.7 billion in revenue, according to a report released by Statista.

The global market for ustekinumab last year was estimated at $17.7 billion, Celltrion added.

Celltrion said its CT-P43, like the reference drug Stelara, can be used to treat patients with psoriasis, psoriatic arthritis, Crohns disease and ulcerative colitis.

Celltrion added it is seeking EMA approval for the same indications that have been labeled for Stelara.

Previously, Celltrion conducted a global phase 3 clinical trial to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

If it wins approval, Celltrion will look to boost its sales.

"If CT-P43 wins the EMA approval, the company will be able to increase competitiveness in the autoimmune disease therapeutics market, where the company has previously launched treatments such as Remsima, Remsima SC and Yuflyma," Celltrion said.

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

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Celltrion seeks approval for Stelara biosimilar in EU - The Investor