Celltrion unveils Phase 3 results for CT-P47

[Courtesy of Celltrion Inc.]

Celltrion Inc. presented results from a Phase 3 study of its biosimilar CT-P47, a biosimilar of tocilizumab (Actemra) that treats rheumatoid arthritis, at the 2024 European Alliance of Associations for Rheumatology (EULAR) conference, the company said on Friday.

The 2024 EULAR, which kicked off in Vienna on Wednesday and runs through Friday, is one of the world‘s most prominent conferences on rheumatic diseases.

According to Celltrion, CT-P47 demonstrated equivalence to the original drug in global clinical trials, with results covering up to 32 weeks out of a 52-week study period involving 471 rheumatoid arthritis patients.

The company also confirmed that separate phase 3 trials for the subcutaneous injection (SC) formulations validated the drug’s efficacy and safety.

Based on these outcomes, Celltrion has filed for product approval for CT-P47 in the United States, Europe, and its home market.

“We will continue to work through the remaining approval procedures to strengthen our autoimmune disease portfolio in the global market,” the company said.