Celltrion's Remsima receives approval in 100 countries in 10 years

South Korea's most valuable biopharmaceutical company Celltrion Inc. said on Tuesday that its antibody biosimilar Remsima (ingredient: infliximab) has been approved in more than 100 countries ten years after its first approval.

Remsima is a TNF-alpha inhibitor that is used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, and psoriasis. Celltrion, which started development in 2006, obtained the world's first approval for Remsima from the Korean Ministry of Food and Drug Safety in July 2012.

Later, more approval came from the European Commission in September 2013 and the US Food and Drug Administration in April 2016. In addition, it was approved in Canada, Japan, and Brazil, and the number of countries in which the company won approval reached 100 as of the end of last year.

IQVIA, a pharmaceutical market research firm, estimates the global market for TNF-alpha inhibitors to be about $58.8 billion in 2021.

Celltrion said that Remsima has a stable market share in major markets such as Europe and the US. Remsima recorded a market share of 53.6% in Europe in the second quarter of last year. As of the third quarter of last year, the US market share was 31.7%.

"We will push for approval of Remsima's follow-up antibody treatments such as Truxima, Herzuma, Yuflyma, and Vegzelma, and expand new pipelines. With this effort, we will seek to continue a stable growth path," said an official of Celltrion.

Write to Jung-Eun Kim at likesmile@hankyung.com