At the American College of Rheumatology (ACR) held on Nov. 6 to 7 (local time), Celltrion released the results of Phase 1 and Phase 3 clinical results of Humira (Component name: Adalimumab) biosimilar CT-P17.
Celltrion submitted two results of the Phase 1 clinical trials conducted on healthy subjects and the results of the Phase 3 clinical trials conducted on patients with rheumatoid arthritis (RA) and was selected as the poster presentation.
Phase I clinical trials conducted on healthy subjects demonstrated an equivalent level of pharmacokinetics and safety compared to Humira, and Phase I clinical trials compared two types -- CT-P17’s Auto-injector (AI) and Pre-filled Syringe (PFS) -- also proved a similar level in pharmacokinetics and safety.
Phase 3 clinical trials for patients with rheumatoid arthritis and severe cases were conducted to assess overall safety, including efficacy, pharmacokinetic (PK), and immunogenicity.
In the main results of the 24-week Phase 3 clinical trials, Celltrion confirmed that the efficacy of CT-P17 was equivalent to that of Humira, and was similar in pharmacokinetic and safety.
CT-P17 is a citrate free product that removes citrate that can cause pain during injections, and unlike conventional Humira biosimilars, it was developed as a high-concentration formulation and has a competitive edge in the market with differentiated strategies.
Humira, the original CT-P17 drug, is a blockbuster drug with global sales of $19.16 billion last year. Based on all the indications approved for Humira, including rheumatoid arthritis, ulcerative colitis and psoriasis, in March this year, Celltrion completed the application for permission of CT-P17 to the European Medicines Agency (EMA), and expects approval of EMA early next year.
"We proved the effectiveness and safety of CT-P17 in global clinical trials and were selected as a poster presentation at this year's ACR following last year," said Lee Sang-joon, senior vice president and head of clinical development division at Celltrion. "Since it was developed as the first high-concentration formulation product of Humira biosimilars, we expect it to have a differentiated competitive edge in the autoimmune disease treatment market."
