Roche Multiple Sclerosis Treatment 'Ocrevus' Approved in Korea

Roche's multiple sclerosis treatment Ocrevus, which had not entered Korea for over seven years since its approval by the U.S. Food and Drug Administration (FDA) in 2017, has received domestic approval.

Roche's autoimmune disease treatment 'Ocrevus (active ingredient: ocrelizumab)'
[Photo by Roche]

The Ministry of Food and Drug Safety announced on the 13th that it had approved Ocrevus from Roche Korea. Ocrevus is used as a treatment for multiple sclerosis. Multiple sclerosis is a chronic disease that occurs in the central nervous system, which consists of the brain, spinal cord, and optic nerves. It is a type of autoimmune disease in which the patient's immune system attacks healthy cells and tissues, destroying the myelin sheath that plays a key role in the central nervous system, causing various central nervous system disorders such as vision loss, motor paralysis, and sensory impairment. It is known that there are approximately 2.3 million patients worldwide.

Ocrevus has a therapeutic effect that suppresses multiple sclerosis by selectively targeting B cells expressing CD20 through a recombinant humanized monoclonal antibody, reducing the number and function of B cells. It was approved by the FDA in 2017 and subsequently approved by the European Medicines Agency (EMA) the following year. In 2022, it recorded sales of $6.7 billion (approximately 9.1736 trillion KRW).

Since a considerable amount of time has passed since its launch, biosimilar development is already underway. Celltrion received approval last year in the U.S. and Europe for the Phase 3 clinical trial plan of CT-P53. Roche is also accelerating the development of a subcutaneous (SC) formulation, which improves dosing convenience compared to the existing intravenous formulation, to fend off such competition. The Phase 3 clinical trial was completed in July last year.

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