Celltrion plans a stage 3 clinical trial for CT-P53 MS biosim in U.S.

[Courtesy of Celltrion]

South Korean biosimilar developer Celltrion Inc. has submitted to the U.S. Food and Drug Administration an application for the approval of a Phase 3 clinical trial for its investigational multiple sclerosis biosimilar CT-P53, according to the Korean pharmaceutical company on Tuesday.

CT-P53 is a biosimilar to Swiss-based drugmaker Roche Holdings AG’s multiple sclerosis drug Ocrevus (Ocrelizumab).

The Phase 3 study will be designed to compare the efficacy, pharmacokinetics and safety of CT-P53 and Ocrevus in a total of 512 patients with relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a chronic and inflammatory rare disorder that affects the central nervous system, comprised of the brain and spinal cord.

“As the first-mover in biosimilars, we will complete the development before the Ocrevus patent expires,” said an unnamed official at Celltrion.

Celltrion filed an Investigational New Drug (IND) application with the European Medicines Agency (EMA) for the Phase 3 clinical trial of CT-P53 in April via the EMA’s Clinical Trials Information System (CTIS).