Celltrion Receives European Marketing Authorization for Autoimmune Disease Treatment 'Aptozma'

Four Products Approved in Europe This Month
Rapid Establishment of an 11-Product Portfolio

Celltrion announced on the 24th that it has obtained marketing authorization from the European Commission (EC) for the biosimilar of Actemra (European brand name RoActemra), "Avtozma (AVTOZMA)".

This marketing authorization for Avtozma was granted for the main indications of the original drugs, including rheumatoid arthritis (RA) and giant cell arteritis (GCA). Celltrion is accelerating commercialization, having obtained marketing authorization for Avtozma in South Korea at the end of last year and in the United States last month.

Avtozma is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in inducing inflammation in the body. By expanding its portfolio to include interleukin inhibitors in addition to the existing tumor necrosis factor alpha (TNF-α) inhibitor product group in the autoimmune disease treatment area, Celltrion expects to broaden the range of patients eligible for treatment.

In addition to Avtozma, Celltrion has consecutively obtained approval for a total of four products this month, including "Idenzel (Aflibercept biosimilar)", "Osenbelt" and "Stoboclo (Prolia-Xgeva biosimilars)", completing the business goal of establishing an "11-product portfolio" in Europe, which was achieved early last year in South Korea.

Looking at the global market sales of the approved products, Actemra is approximately 4 trillion KRW, Aflibercept about 13 trillion KRW, and Prolia-Xgeva combined about 9 trillion KRW, totaling 26 trillion KRW. The combined global market size of the 11 major products currently sold or approved, including ▲Remsima, Remsima SC·Zimpentra, Uplyma, Stekima, Avtozma (autoimmune disease treatments) ▲Herzuma, Truxima, Vegzelma (anticancer drugs) ▲Omriclo (allergy treatment) ▲Idenzel (ocular disease treatment) ▲Stoboclo-Osenbelt (bone disease treatments), reaches approximately 150 trillion KRW.

Celltrion plans to strengthen its product lineup in the rapidly growing autoimmune disease market and significantly expand treatment areas such as bone diseases and ophthalmic diseases, further enhancing synergy among products in major countries including Europe.

A Celltrion official stated, "Through consecutive product approvals in Europe, one of the major markets, we have successfully achieved the goal of establishing an '11-product portfolio by 2025' and once again demonstrated our in-house drug development capabilities to the market. We will focus on the remaining approval processes and commercialization to accelerate global market entry and speed up growth."