Celltrion said on Friday it filed a marketing authorization application with the European Medicines Agency (EMA) for CT-P43, a biosimilar referencing Stelara (ingredient: ustekinumab) to treat autoimmune diseases.

Stelara, the original drug, is an interleukin (IL)-12 and 23 inhibitor developed by Janssen for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Celltrion confirmed similar efficacy, pharmacokinetic, and safety results in a global phase 3 clinical trial of CT-P43 in 509 patients with plaque psoriasis in Korea, Poland, Ukraine, and Estonia.

Based on these results, the company submitted a full-label application to the EMA for the full range of indications covered by the original drug, and plans to later file for approval in other key countries.

According to IQVIA, the global market size of ustekinumab was $17.77 billion in 2022. Stelara is a blockbuster product buts its substance patent is set to expire in September this year in the U.S. and July 2024 in Europe.

With the EMA marketing authorization of CT-P43 and full-scale commercialization, Celltrion expects to have an interleukin inhibitor autoimmune therapeutic product in addition to its existing TNF-α (tumor necrosis factor) inhibitor product lineup of Remsima IV, Remsima SC, and, Yuflyma thus solidifying its leading position in the global autoimmune therapeutics space.

"In addition to Remsima, Yuflyma, and CT-P43, we are also accelerating the acquisition of follow-on products, including CT-P47 which is a rheumatoid arthritis biosimilar to Actemra (ingredient: tocilizumab) and CT-P53 which is a multiple sclerosis biosimilar to Ocrevus (ingredient:ocrelizumab), to strengthen our leadership position in autoimmune diseases,” said a Celltrion official. "We will continue to work with regulatory authorities to complete the remaining approval processes to bring our  biologics to more patients."