Celltrion disclosed the results of the first clinical trial stage of Humira biosimilar CT-P17, a treatment of autoimmune disease at the 2019 American College of Rheumatology (ACR) Society held in Atlanta, U.S. on Nov. 10 (local time).
CT-P17 is the biosimilar of Humira, the number one blockbuster drug in global sales (approximately 23 trillion won in 2018). Celltrion has been developing a strategy that is completely different from conventional biosimilars with a high concentration system that emphasizes patients' convenience by reducing dosage.
Moreover, CT-P17 has secured cost competitiveness based on Celltrion's clinical development and production know-how. Unlike previous Humira biosimilars, CT-P17 is being developed as a citrate free (CF) form, which removes citrate that can cause pain in injection, so it has sufficient market competitiveness against competing products.
Also in Europe, the market is already largely reorganized with original products being improved from low-concentration to high-concentration ones, and Celltrion biosimilar is known to be the only high-concentration one.
Celltrion prescribed Humira and CT-P17 in 30 rheumatoid arthritis patients to directly compare the safety and pharmacokinetics with Humira in the ACR, and announced clinical first-phase results comparing safety and pharmacokinetics for 120 days after taking the drug.
It yielded similar results in CT-P17 administration and Humira administration, and confirmed the similarity between CT-P17 and Humira.
Celltrion plans to begin the process of applying for the marketing license of CT-P17 to the European Medicines Agency (EMA) early next year when the ongoing third phase of global clinical trials is completed.