'Infliximab' Changing the Landscape of Inflammatory Disease Treatment

Celltrion's infliximab biosimilar 'Remsima'

[Asia Economy Reporter Lee Gwanju] The drug 'infliximab,' used for excessive and persistent inflammatory diseases caused by abnormalities in the immune system, is completely changing the landscape of inflammatory disease treatment. In particular, recent studies have confirmed that treatment outcomes for pediatric ulcerative colitis, which significantly reduces the quality of life for children and adolescents, have markedly improved compared to before the introduction of infliximab. The strong performance of Korean bio companies in the global infliximab market, estimated at 76 trillion KRW annually, is also noteworthy.

Inflammation Treatment by Inhibiting Tumor Necrosis Factor

Inflammation is a normal immune response that defends the body. However, when the balance of the immune system is disrupted by various causes, it attacks the body itself rather than external substances. This is commonly called an 'autoimmune disease.' Excessive and chronic inflammation significantly reduces quality of life. When it occurs in the digestive system, it manifests as Crohn's disease or ulcerative colitis; in the joints, as rheumatoid arthritis; and in the skin, as psoriasis.

Infliximab works by inhibiting tumor necrosis factor (TNF-α). TNF-α normally regulates immune cells and inflammation in the body, but when produced excessively, it causes chronic inflammatory diseases. Infliximab blocks TNF-α from binding to its receptor and activating it, thereby showing anti-inflammatory and immunosuppressive effects. It is currently used to treat various chronic inflammatory diseases caused by immune system abnormalities, including Crohn's disease, ankylosing spondylitis, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and psoriasis.

"Excellent Effect in Treating Pediatric Ulcerative Colitis"

Infliximab has been used to treat pediatric ulcerative colitis in Korea since 2012. Pediatric ulcerative colitis refers to an inflammatory bowel disease in children and adolescents under 18 years old, characterized by inflammation or ulcers in the mucosa or submucosa of the colon. Symptoms include abdominal pain, diarrhea, dehydration, fever, vomiting, and weight loss.

The use of infliximab has greatly improved treatment outcomes for patients. A research team led by Professor Kim Mijin and Clinical Instructor Kwon Iyong from the Department of Pediatrics at Samsung Seoul Hospital evaluated treatment outcomes by dividing patients into a pre-infliximab introduction group (48 patients) and a post-introduction group (62 patients). The rate of endoscopic remission was only 29.2% before infliximab introduction but increased to 50% afterward. The relapse rate was 47.9% in the pre-introduction group but decreased to 25.8% in the post-introduction group.

The research team interpreted that the use of infliximab created an important turning point in the treatment of pediatric ulcerative colitis. Professor Kim explained, "In the past, the goal was to expect symptom improvement or delay relapse as much as possible, but after the introduction of biologics like infliximab, the focus shifted toward eliminating the ulcers themselves."

Korean Bio Companies Targeting the Global Market

According to IQVIA, a global pharmaceutical market research firm, the global TNF-α inhibitor market size reached approximately $58.822 billion (about 76.6 trillion KRW) in 2021. Of this, the U.S. market accounts for 72%, or $42.786 billion (about 55.7 trillion KRW). The infliximab market is led by Janssen's original drug 'Remicade,' but competition from latecomers is intensifying.

The most representative company is Celltrion. Celltrion's biosimilar 'Remsima' increased its U.S. market share to 31.7% as of the third quarter of last year. In the European market, it holds over 50% market share. Celltrion recently completed the U.S. Food and Drug Administration (FDA) approval application for RemsimaSC, which changes the existing intravenous (IV) formulation to a subcutaneous (SC) injection form.

A Celltrion representative said, "RemsimaSC has already shown a market share exceeding 12% in Europe, where it was introduced earlier, by emphasizing rapid dosing effects and formulation convenience, rapidly expanding its influence. If RemsimaSC secures new drug status in the U.S., the world's largest infliximab market, it will be able to provide high-quality pharmaceutical treatment opportunities to more patients."

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