Celltrion: "Remsima Shows Similar Efficacy to Original Remicade"

[Asia Economy Reporter Seol Gina Jo] Celltrion's biosimilar for autoimmune disease treatment, 'Remsima' (development name CT-P13), demonstrated safety and efficacy comparable to Janssen's original drug 'Remicade' with the same ingredient in clinical trials.

On the 14th, Celltrion announced that it disclosed the final results of a long-term safety and efficacy observational study of intravenous Remsima as an e-Poster at the Asian Organization for Crohn's & Colitis (AOCC) conference. AOCC is an international academic conference where experts on inflammatory bowel disease (IBD) gather to share the latest insights on diagnosis, treatment, and clinical practice. The event is held both on-site in Guangzhou, China, and online from the 14th to the 16th.

Celltrion conducted a 5-year clinical trial involving 736 patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and ankylosing spondylitis (AS) in Korea and Europe. The long-term observation of patients who received Remsima intravenously and those who switched from the original drug to Remsima showed no notable safety issues. Furthermore, there were no differences between the two groups in terms of immunogenicity and efficacy. The disclosed study results were published in the international journal 'Advances in Therapy' in July of this year.

Remsima obtained marketing authorization from the Korean Ministry of Food and Drug Safety in 2012, followed by approval from the European Medicines Agency (EMA) in 2013 and the U.S. Food and Drug Administration (FDA) in 2016. Currently, in the European market, it holds a market share exceeding that of the original product (51.8% as of Q1 this year), and in the U.S., where biosimilar-friendly policies continue, it has achieved a market share of 17.2% as of Q2 this year, showing steady growth.

A Celltrion official stated, "Remsima has once again proven its safety and efficacy in long-term clinical trials targeting patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease," adding, "With Remsima demonstrating equivalent effects to the original product and being supplied at a reasonable price, it contributes to reducing the global financial burden of autoimmune disease treatment. Additionally, as the global supply of the subcutaneous injection formulation ‘RemsimaSC,’ which improves dosing convenience, accelerates, patient accessibility to Remsima is expected to further improve."