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Celltrion’s Ph III IND For CT-P53 Ocrelizumab Biosimilar to Genentech’s Ocrevus® Partially Approved By EMA

Aug 22, 2023

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.

In the same week on 24 August 2023, Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on more than 10 US formularies since its US launch on 17 April 2023.

Celltrion submitted its phase III IND plan for CT-P53 to the US FDA on 15 May 2023.