Celltrion Submits Phase 3 Plan for Biosimilar Multiple Sclerosis Treatment

Celltrion announced on the 2nd that it has submitted an Investigational New Drug application (IND) for the Phase 3 clinical trial of 'CT-P53,' a biosimilar of the multiple sclerosis treatment 'Ocrevus' (active ingredient ocrelizumab), and has commenced the global Phase 3 clinical trial.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

원본보기 아이콘

On the 28th of last month, Celltrion submitted the IND to the Clinical Trial Information System (CTIS) managed by the European Medicines Agency to proceed with the global Phase 3 clinical trial of CT-P53. In this Phase 3 trial, a total of 512 patients with relapsing-remitting multiple sclerosis will be enrolled to conduct comparative studies on the efficacy, pharmacokinetics, and safety between CT-P53 and Ocrevus.

The original drug Ocrevus, developed by Roche, is a blockbuster autoimmune disease treatment that recorded approximately 9 trillion KRW in global sales last year. Ocrevus is used for the treatment of ▲relapsing multiple sclerosis (RMS) and ▲primary progressive multiple sclerosis (PPMS).

A Celltrion official stated, "With the submission of the IND for the global Phase 3 clinical trial of CT-P53, we have officially started the global clinical trial, further strengthening the competitiveness of our pipeline in the autoimmune disease treatment field, where we have shown strengths. We will do our best in development to successfully conduct the global trial and ensure that high-quality biopharmaceuticals can be supplied to patients as soon as possible."

Meanwhile, Celltrion is preparing and progressing the biosimilar approval processes for up to five products within this year, including the biosimilars of Xolair (CT-P39), Stelara (CT-P43), Eylea (CT-P42), Prolia (CT-P41), and Actemra (CT-P47).

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.