Celltrion to seek FDA approval for sale of Remsima SC by year-end

Celltrion Inc. said it has confirmed the effectiveness and safety of Remsima SC in its third-phase global clinical trials, conducted on 438 patients of ulcerative colitis and 343 Crohn's disease patients.

The South Korean pharmaceutical company claims Remsima is the world’s first biosimilar monoclonal antibody. It is referencing Janssen's Remicade to treat autoimmune diseases.

The company announced Remsima SC has shown statistically significant superiority in treatment during the latest clinical trials when compared to a placebo.

A Celltrion employee told The Korea Economic Daily that based on the positive results, the company will prepare to gain United States Food and Drug Administration (FDA) approval. 

In addition to Remsima, other biosimilars of Janssen’s Remicade are available in the market, such as those developed by Samsung Bioepis and Amgen Inc.

According to industry reports, the original Remicade has 53.5% share in the US while Celltrion’s Remsima has 31.7% share.

“Following the success of Remsima IV, if we can also release the SC version, we will be able to dominate the treatments for inflammatory bowel diseases,” a Celltrion employee said. 

Write to Jae-Young Han at jyhan@hankyung.com
Jee Abbey Lee edited this article.