Celltrion Receives Additional Domestic Approval for Autoimmune Disease Treatment 'Aptozma' SC Formulation

Both IV and SC Formulations Approved

Celltrion announced on the 13th that it has obtained marketing authorization from the Ministry of Food and Drug Safety for the subcutaneous (SC) formulation of the autoimmune disease treatment biosimilar 'Actemra (ACTEMRA, generic name: tocilizumab)' called 'Avtosma (AVTOZMA, development code CT-P47)'.

Based on the results of the global Phase 3 clinical trial, Celltrion applied for domestic marketing authorization for the Avtosma SC formulation and received approval for the indication of rheumatoid arthritis (RA). Last year, Celltrion secured the status of 'first mover' in the Actemra biosimilar field by being the first in Korea to obtain approval for the intravenous (IV) formulation of Avtosma.

On this day, Celltrion also obtained approval for the 80 mg/4 ml dosage of the Avtosma IV formulation, thereby securing the entire dosage lineup of the IV formulation held by the original product, including the previously approved 200 mg/10 ml and 400 mg/20 ml dosages.

By adding the SC formulation of Avtosma and securing additional dosages of the IV formulation, Celltrion expects that treatment options for medical professionals will expand considering patients' conditions and convenience, significantly strengthening competitiveness in the domestic tocilizumab market.

The original drug of Avtosma, Actemra, is an interleukin (IL) inhibitor that suppresses the IL-6 protein involved in inducing inflammation in the body, thereby reducing inflammation. It recorded global sales of approximately 2.645 billion Swiss francs (about 4 trillion KRW) last year.

Celltrion's advance into the global tocilizumab market, including the United States, the world's largest pharmaceutical market, is progressing smoothly. Last year, it received a recommendation for marketing authorization approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), awaiting final approval. Additionally, last month, it obtained approval from the U.S. Food and Drug Administration (FDA) for both the IV and SC formulations of Avtosma, making global market entry more tangible.

Celltrion plans to further strengthen its position in the global autoimmune disease treatment market based on a solid lineup of five autoimmune disease products, ranging from tumor necrosis factor alpha (TNF-α) inhibitors such as Remsima, Remsima SC (U.S. brand name: Gymsentra), and Uplima, to interleukin (IL) inhibitors such as Stekima and Avtosma.

In particular, the interleukin inhibitor product group is expected to drive sales growth through portfolio synergy effects, with Stekima recently launched in major global countries including Europe, and Avtosma soon to be launched.

A Celltrion official stated, "Following the United States, we have obtained approval for both the IV and SC formulations of Avtosma domestically, strengthening our autoimmune disease portfolio. As synergy among the five products that can provide optimal treatment options for autoimmune disease patients is anticipated, we will do our best to proceed smoothly with the remaining approval and commercialization processes to accelerate sales growth."

Meanwhile, Celltrion plans to build a lineup of 22 biosimilar products by 2030 to further strengthen its dominance in the global market and accelerate sales growth.