Celltrion Applies for Domestic Approval of Actemra Biosimilar CT-P47

Celltrion announced on the 28th that it has completed the domestic marketing authorization application for CT-P47, a biosimilar developed from Actemra, a treatment for autoimmune diseases.

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

Actemra is a treatment for rheumatoid arthritis and other conditions developed by the Swiss multinational pharmaceutical company Roche. It inhibits interleukin (IL)-6, a protein that causes inflammation in the body. Last year, it formed a massive market with global sales approaching 2.63 billion Swiss francs (approximately 4 trillion KRW).

Celltrion has applied for marketing authorization for CT-P47 for all indications that the original drug Actemra holds domestically, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. The company has already completed marketing authorization applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and plans to apply for marketing authorization in other global countries such as Canada.

This application was based on the results of the global Phase 3 clinical trial of CT-P47. Through the Phase 3 clinical trial involving 471 rheumatoid arthritis patients, Celltrion confirmed the equivalence and similarity of CT-P47 compared to the original drug.

Celltrion expects that once marketing authorization is obtained for CT-P47, it will be able to expand its autoimmune disease treatment portfolio beyond tumor necrosis factor (TNF)-α inhibitors such as Remsima and Yuflyma to include interleukin inhibitors. In addition to the Actemra biosimilar, Celltrion is also proceeding with the approval process for the Stelara biosimilar CT-P43 both domestically and internationally as an interleukin inhibitor.

Since Actemra is available in both subcutaneous injection and intravenous injection formulations, Celltrion plans to release both formulations of CT-P47 to allow medical professionals to choose and prescribe based on patient condition and convenience. Although the patent for Actemra’s subcutaneous injection was originally set to expire in 2031, Celltrion succeeded in invalidating the patent by winning a patent dispute against Roche.

Roche's autoimmune disease treatment Actemra [Photo by JW Jungwoo Pharmaceutical]

A Celltrion official stated, “Following the U.S. and Europe, we have completed the marketing authorization application for CT-P47 domestically as well, continuing our efforts to expand our autoimmune disease portfolio. We will do our best to proceed smoothly with the remaining approval processes with regulatory authorities in each country to supply high-quality biopharmaceuticals to patients both domestically and internationally at an early stage.”

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