Celltrion said Monday that it has submitted a marketing authorization application to the U.S. FDA for CT-P47, a biosimilar to Roche’s Actemra (tocilizumab) for the treatment of autoimmune diseases.

Based on the global phase 3 results of CT-P47, which included 471 patients with rheumatoid arthritis (RA), Celltrion filed marketing authorization for giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and Covid-19 indications.

The trial measured key markers of RA activity in two groups, one receiving CT-P47 and the other receiving Actemra, and the difference between the two groups met predefined equivalence criteria, Celltrion said.

With the result of the phase 3 study, Celltrion plans to accelerate its marketing authorization efforts in the U.S. and other key global markets, including Europe and Canada.

In addition, following approval of CT-P47, Celltrion targets to launch CT-P47 in both subcutaneous (SC) and intravenous (IV) formulations, similar to the original drug Actemra, to provide healthcare professionals with the option to prescribe based on patient condition and convenience.

Actemra is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein, which causes inflammation in the body.

According to pharmaceutical market research firm IQVIA, Actemra’s global sales recorded approximately $2.84 billion in 2022, In the U.S. alone, the drug generated $1.47 billion in sales over the same period.

"We will expand our autoimmune disease portfolio with interleukin inhibitors following tumor necrosis factor-alpha (TNF-α) inhibitors such as Remicade biosimilar Remsima SC (infliximab) and Humira biosimilar Yuflyma (adalimumab) in the global market and strengthen our market dominance,"  said a Celltrion official.