Celltrion wins phase 3 IND approval for Ocrevus biosimilar in US
Jeong Min Nam
Jun 15, 2023 (Gmt+09:00)
South Korea's biopharmaceutical company Celltrion Inc. announced that it received on Thursday approval from the US Food and Drug Administration (FDA) for the phase 3 investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ingredient: ocrelizumab), a treatment for multiple sclerosis.
This IND approval was obtained approximately a month after Celltrion submitted the global phase 3 IND plan for CT-P53 to the FDA in May. The company plans to conduct comparative studies on efficacy, pharmacokinetics and safety between CT-P53 and the original drug Ocrevus in a total of 512 relapsing-remitting multiple sclerosis patients.
The original drug of CT-P53, Ocrevus, is a blockbuster autoimmune disease treatment developed by Roche. It is used for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. Ocrevus recorded global sales of approximately $7 billion as of last year. It holds the top position in the global multiple sclerosis market, with the US market accounting for over 70% of the total market size at $5.2 billion.
"With the clinical approval of our new pipeline product CT-P53 in the United States, we are entering the main clinical process and preparing for entering the US ocrelizumab market, which is estimated to be over $4.7 billion," a Celltrion official said. "We will do our best to accelerate the phase 3 clinical trials and make CT-P53 a first mover in the Ocrevus biosimilar market."