Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that the EMA has partially approved its phase III IND for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus® to treat multiple sclerosis. The trial will assess biosimilarity of CT-P53 and Ocrevus®. The clinical trial plan has been divided into two parts Part 1 (assessment of clinical design and product characteristics) and Part 2 (assessment of national and institution-level documents). The trial cannot commence until Part 2 has been approved by the EMA.
Celltrion submitted its phase III IND plan for CT-P53 to the US FDA on 15 May 2023.Print Page Mail Article