Celltrion has announced that its biosimilar drug "CT-P53" has received Phase 3 Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS).
This approval comes just a month after Celltrion submitted a global phase 3 clinical trial plan for CT-P53 to the FDA in May.
The clinical trial will involve 512 patients with relapsing multiple sclerosis and will compare the efficacy, pharmacokinetics, and safety of CT-P53 with the original drug, Ocrevus (Ocrelizumab).
Ocrevus, developed by Roche, is a widely used autoimmune disease treatment for Relapsing-Remitting Multiple Sclerosis (RMS) and Primary Progressive-Relapsing Multiple Sclerosis (PPMS).
It has been a blockbuster drug, generating approximately 9 trillion won in global sales as of 2022. Ocrevus dominates the global MS market and holds the number one position in terms of sales, with the U.S. market alone accounting for over 70% of the total market size, amounting to about 6.66 trillion won.
"With the clinical approval of CT-P53 and our entry into the U.S. market, we have initiated full-scale clinical procedures and are prepared to compete with Ocrelizumab, which is valued at over 6 trillion won," said a spokesperson from Celltrion. "We are committed to expediting the phase 3 clinical trial process to position CT-P53 as the leading biosimilar of Ocrevus."
