FDA approves Celltrion's phase 3 trial of Zymfentra for rheumatoid arthritis

Celltrion said Monday that the U.S. Food and Drug Administration (FDA) has approved a phase 3 clinical trial of its Remicade biosimilar, Zymfentra (CT-P13 SC, infliximab), for the indication of rheumatoid arthritis (RA).

Celltrion will analyze the efficacy and safety of Zymfentra vs. placebo in 189 patients with RA.

Zymfentra is a subcutaneous (SC) formulation of infliximab, a tumor necrosis factor (TNF)-α inhibitor developed by Celltrion. Celltrion launched Zymfentra in the U.S. in March and has signed agreements with prominent pharmacy benefit managers (PBMs) to ensure stable supply in the market.

Zymfentra is prescribed in the U.S. for inflammatory bowel disease (IBD), and the addition of RA will likely expand its impact in the U.S. autoimmune disease market, according to Celltrion.

In Europe, Ramsima SC (the European brand name for CT-P13 SC) is already widely prescribed for IBD and RA patients. In the first quarter of this year, it had a 22 percent market share in five major European countries. Combined with its intravenous (IV) formulation, Remsima has a 75 percent market share.

According to pharmaceutical market research firm IQVIA, the global RA market was valued at about $42.43 billion (55.16 trillion won) in 2023, with the U.S. market accounting for about $30.58 billion, or 72 percent of the global total.

By increasing the RA indication, Celltrion aims to expand Zymfentra's U.S. target market to about 53.23 trillion won.

“As we enter the full-scale clinical process with the FDA's approval of phase 3 for the additional RA indication, we will do our best to make Zymfentra a global blockbuster by conducting global clinical trials smoothly,” a Celltrion official said.