Celltrion submits phase III IND plan to FDA for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus®

May 15, 2023

Korea Biomed reported that Celltrion submitted a phase III investigational new drug (IND) plan to the FDA for its CT-P53, biosimilar to Genentech’s Ocrevus® (ocrelizumab), used to treat multiple sclerosis.  The phase III global clinical trial will be a comparative study on the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus® on patients with recurrent palliative multiple sclerosis.

Celltrion recently reported US$126M profit in Q1 2023, and increased its operate profit for Q1 by 41.1% on-year.

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