Celltrion: "Autoimmune Disease Treatment CT-P17 Shows Efficacy and Safety Similar to Original"

Presentation of Key Phase 1 and Phase 3 Clinical Results at the American Rheumatology Society Meeting

[Asia Economy Reporter Seo So-jung] Celltrion's autoimmune disease treatment Humira biosimilar (biopharmaceutical generic) 'CT-P17' has been confirmed to have similar efficacy and safety to the original drug.

Celltrion announced this after presenting the Phase 1 clinical trial results and key Phase 3 clinical data of CT-P17 at the American College of Rheumatology (ACR) held on the 6th and 7th (local time).

The American College of Rheumatology is one of the largest rheumatology societies worldwide. Celltrion submitted two Phase 1 clinical trial results conducted on healthy subjects and key Phase 3 clinical results conducted on rheumatoid arthritis patients, which were selected for poster presentation.

In the Phase 1 clinical trial conducted on healthy subjects, pharmacokinetics and safety were proven to be equivalent to Humira. Additionally, in the Phase 1 trial comparing the two forms of CT-P17, Auto-injector and Pre-filled Syringe, pharmacokinetics and safety were also demonstrated to be similar.

The Phase 3 clinical trial conducted on patients with moderate to severe rheumatoid arthritis was carried out to evaluate overall efficacy, pharmacokinetics, immunogenicity, and safety. In the key results of the 24-week Phase 3 trial, Celltrion confirmed that the efficacy of CT-P17 is equivalent to Humira, and pharmacokinetics and safety were similar as well.

CT-P17 is a product developed with a high-concentration formulation, unlike existing Humira biosimilars, by removing citrate, which can cause pain during injection. The original drug of CT-P17, Humira, recorded global sales of $19.168 billion last year, making it a blockbuster drug.

In March this year, Celltrion completed the application for CT-P17 approval to the European Medicines Agency (EMA) based on all indications approved for Humira, including rheumatoid arthritis, ulcerative colitis, and psoriasis, and expects EMA approval early next year.

Lee Sang-jun, Senior Vice President and Head of Clinical Development at Celltrion, said, "CT-P17's efficacy and safety have been proven in global clinical trials, and it was selected for poster presentation at this year's ACR following last year. As the first high-concentration formulation product developed among Humira biosimilars, it is expected to have differentiated competitiveness in the autoimmune disease treatment market."

At this conference, clinical results of RemsimaSC, the world's first subcutaneous injection formulation of infliximab, were also presented. Celltrion evaluated the immunogenicity and the impact of body mass index (BMI) of RemsimaSC and confirmed that there is no difference in immunogenicity between intravenous (IV) and subcutaneous (SC) formulations, and BMI does not affect the results of RemsimaSC administration.

Additionally, a clinical trial comparing the usability of RemsimaSC Auto-injector and Pre-filled Syringe types in rheumatoid arthritis patients confirmed no difference in usability.

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