Celltrion Enters $9 Trillion Autoimmune Disease Treatment Market... Applies for Phase 3 Clinical Trial in the US

Celltrion is accelerating the initiation of Phase 3 clinical trials for 'CT-P53,' a biosimilar of the multiple sclerosis treatment 'Ocrevus' (generic name: ocrelizumab) that it is developing.

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

On the 16th, Celltrion announced that it submitted the Investigational New Drug application (IND) for Phase 1 and 3 clinical trials of CT-P53 to the FDA on the 15th (local time). This clinical trial will be conducted as a 96-week randomized, active-controlled, double-blind study comparing the efficacy, pharmacokinetics, pharmacodynamics, and safety between CT-P53 and Ocrevus in 512 patients with relapsing-remitting multiple sclerosis. Last month, the IND for this clinical trial was also submitted to the Clinical Trials Information System (CTIS) managed by the European Medicines Agency (EMA).

Ocrevus is a blockbuster autoimmune disease treatment from Roche. It was approved by the FDA in 2017 and received EMA approval the following year. It has not yet been approved in South Korea. In addition to relapsing-remitting multiple sclerosis, for which Celltrion is conducting clinical trials, Ocrevus is also used to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). As of last year, it maintained the number one global sales position in the multiple sclerosis market with sales of 6.036 billion Swiss francs (approximately 9 trillion KRW).

Multiple sclerosis is an autoimmune disease in which the body's immune system destroys the myelin sheath, the nerve fiber covering within nerve cells, due to genetic or environmental factors. When the myelin sheath is damaged, various central nervous system disorders such as vision loss, motor paralysis, and sensory impairment occur depending on the damaged area. It is estimated that there are more than 2 million patients worldwide.

Through this clinical trial, Celltrion stated, "We plan to demonstrate biosimilarity through efficacy, pharmacokinetics, pharmacodynamics, and safety results of CT-P53 compared to the original product. Furthermore, we expect to expand the market and increase sales by obtaining approval for all indications (full-label), including not only relapsing-remitting multiple sclerosis but also other multiple sclerosis types approved for the original product.

A Celltrion representative said, "With the submission of the IND for CT-P53 to global regulatory agencies, we have officially entered the global clinical process. Based on our unparalleled experience and know-how accumulated in the autoimmune disease field, we will accelerate the development of this product. We will do our best to complete development before the expiration of Ocrevus's substance patent to secure competitiveness as a biosimilar first mover."

This content was produced with the assistance of AI translation services.