Celltrion said Tuesday that it has received approval for a phase 3 clinical trial in Europe for Zymfentra (CT-P13 SC), a biosimilar subcutaneous formulation of Remicade (infliximab), in the indication of rheumatoid arthritis.

The study is a 52-week, randomized, placebo-controlled, double-blind, parallel-group trial in 189 patients with moderate-to-severe rheumatoid arthritis. The primary objective is to demonstrate the superiority of CT-P13 SC over placebo through clinical response according to ACR20 at Week 12.

Zymfentra is a subcutaneous injection formulation of Remicade biosimilar Remsima IV, which significantly improves patients' dosing convenience. It has completed a phase 3 study in adult patients with ulcerative colitis and Crohn's disease and is approved in multiple countries, including the U.S. and Europe.

Celltrion expects the rheumatoid arthritis trial to expand the product's indications.

“This phase 3 trial in rheumatoid arthritis will allow us to expand the indication to include adult ulcerative colitis and Crohn's disease and provide treatment opportunities for more patients,” Celltrion said in a public filing.