Celltrion scores approval for Stelara biosimilar in Europe

Celltrion said Monday that its biosimilar to Janssen’s Stelara (ustekinumab), named Steqeyma (development code: CT-P43), has received approval from the European Commission (EC) for treating multiple chronic inflammatory diseases.

The approval allows Steqeyma to cover all indications held by Stelara, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease. This follows a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in late June, which recommended granting marketing authorization for Steqeyma. 

With this approval, Celltrion has now secured marketing  authorization for Steqeyma in Europe, in addition to previous approvals in Korea and Canada in June and July.

Alongside existing tumor necrosis factor (TNF) inhibitors like Zymfentra (infliximab), also known as Remsima SC outside the U.S., and Yuflyma (adalimumab), the inclusion of the interleukin (IL) inhibitor Steqeyma broadens the range of available treatments.

According to pharmaceutical market research firm IQVIA, the global market for ustekinumab was valued at approximately $20.4 billion last year, with the European market accounting for about $3.1 billion.

Celltrion plans to enhance its market position through rapid commercialization and strategic bundling of products. The company said the addition of Steqeyma to its portfolio is expected to accelerate its efforts in the global autoimmune disease treatment market. 

"We are committed to rapidly launching Steqeyma in key global markets to build a strong autoimmune disease product portfolio and meet patient needs,” said a Celltrion official. “We will also intensify the development of our pipeline to increase market dominance."