Celltrion's Development of '4 Trillion' Market Actemra Biosimilar Progresses Smoothly

Published 14 Jun.2024 08:55(KST)

Celltrion announced on the 14th that it disclosed clinical results of CT-P47, a biosimilar of Actemra, a rheumatoid arthritis treatment, through two poster presentations at the 2024 European League Against Rheumatism (EULAR 2024).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

EULAR is one of the world's most prestigious conferences where experts on rheumatic diseases from around the globe gather to share the latest clinical results and trends in drug development. This year, it is being held from June 12 to 15 (local time) in Vienna, Austria.

At this conference, Celltrion presented poster results up to 32 weeks from a 52-week global Phase 3 clinical trial of the intravenous formulation of CT-P47 involving 471 rheumatoid arthritis patients. The clinical results confirmed equivalent efficacy of CT-P47 compared to the original drug by meeting the pre-defined equivalence criteria in the primary efficacy endpoint. Similarities were also confirmed in safety and pharmacokinetic characteristics. In the group that switched from the original product to CT-P47, similar efficacy, safety, and pharmacokinetic profiles were observed over 8 weeks compared to groups maintained on each product.

Results related to the subcutaneous injection formulation were also disclosed in a separate poster. In the Phase 3 usability trial of the auto-injector device for RA patients, high usability, self-injection success rate, efficacy, and safety were confirmed. Additionally, a domestic Phase 1 clinical trial comparing the prefilled syringe (PFS) and auto-injector devices of CT-P47 demonstrated pharmacokinetic equivalence and similarity in safety.

Based on these clinical results, Celltrion applied for marketing authorization for CT-P47 covering all indications held by Actemra in major countries including South Korea, the United States, and Europe earlier this year. Actemra is an autoimmune disease treatment developed by the Swiss multinational pharmaceutical company Roche. It reduces inflammation by inhibiting interleukin (IL)-6, a protein that causes inflammation in the body. Besides rheumatoid arthritis, it is used to treat giant cell arteritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. Last year, Actemra formed a massive market with global sales approaching 2.63 billion Swiss francs (approximately 4 trillion KRW). Since Actemra is available in both intravenous and subcutaneous formulations, CT-P47 is also being prepared for launch in both formulations to allow selective prescription by healthcare professionals.

Currently, Celltrion supplies TNF-alpha (tumor necrosis factor-alpha) inhibitors Remsima, Remsima SC, and Upflima in the autoimmune disease treatment market. Furthermore, having recently received approval from the Korean Ministry of Food and Drug Safety on the 12th for another interleukin (IL) inhibitor, Stekima, the addition of CT-P47 is expected to establish a total portfolio of five autoimmune disease treatments covering both TNF-alpha inhibitors and interleukin inhibitors.

A Celltrion official stated, “CT-P47, which reconfirmed efficacy and safety compared to the original drug at this EULAR, has already completed marketing authorization applications in major global countries. We will do our best to proceed smoothly with the remaining approval processes to build a strong autoimmune disease portfolio in the global market and accelerate the company’s growth.”