Celltrion (KRX:068270) received U.S. Food and Drug Administration approval to launch a Phase 3 clinical trial in the U.S. for Zymfentra (CT-P13 SC), a subcutaneous version of its infliximab biosimilar, in patients with rheumatoid arthritis.

The study will enroll 296 patients over 52 weeks and aims to demonstrate superiority to placebo in reducing disease symptoms by Week 12. Zymfentra is already approved in several countries for ulcerative colitis and Crohn's disease, and the new trial could extend its use to rheumatoid arthritis.

Celltrion said the US FDA does not issue separate approval notices for new Phase 3 trials, with confirmation deemed effective 60 days after submission.