Celltrion Receives US Approval for Autoimmune Disease Treatment 'Aptozma'

Accelerating Efforts to Capture the 4 Trillion KRW Market

Celltrion announced on the 31st that its autoimmune disease treatment 'Actemra (ACTEMRA·generic name tocilizumab)' biosimilar 'Avtozma (AVTOZMA·development code CT-P47)' has received approval from the U.S. Food and Drug Administration (FDA).

Based on the results of global Phase 3 clinical trials, Celltrion applied for U.S. approval of Avtozma last year, securing authorization for major indications including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and coronavirus disease 2019 (COVID-19).

Since the original drug Actemra is available in two formulations?subcutaneous injection (SC) and intravenous injection (IV)?Avtozma was also approved in both formulations to allow healthcare professionals to selectively prescribe based on the patient's condition and convenience.

Actemra is an interleukin (IL)-6 inhibitor that reduces inflammation by suppressing the IL-6 protein involved in triggering inflammation in the body. It recorded global sales of approximately 2.63 billion Swiss francs (about 4 trillion KRW) in 2023. Notably, sales in the U.S. market alone reached 1.638 billion USD (about 2.2932 trillion KRW), accounting for more than half of the total sales, making it the largest contributor to global revenue.

Prior to this U.S. approval, Celltrion secured the first domestic approval for Avtozma last month, establishing its position as a 'First Mover' in the Actemra biosimilar field. Additionally, it recently received a positive recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), with final approval procedures underway. Celltrion plans to accelerate its entry into major global markets based on this.

Through this marketing authorization, Celltrion aims to establish a stable supply chain in the U.S. and rapidly expand its market share with competitive pricing strategies and high-quality products. In particular, Avtozma is expected to provide practical benefits to patients and healthcare providers in the U.S. by offering an economical treatment option while delivering equivalent efficacy and safety compared to the original drug.

A Celltrion representative stated, "With approval in the world's largest pharmaceutical market, the U.S., we plan to swiftly complete the remaining commercialization processes and actively pursue the global autoimmune disease treatment market. We will do our best to provide patients with faster and more stable access to treatments."

Meanwhile, Celltrion has demonstrated its drug development capabilities by achieving early realization of its goal to establish an '11-product portfolio by 2025,' which was presented early last year, through a series of recent approvals for follow-up pipelines. Celltrion aims to build a portfolio of 22 biosimilars by 2030 and further strengthen its dominance in the global market.