[News Space=Reporter seungwon lee] Celltrion announced on the 13th that it had obtained product approval from the Ministry of Food and Drug Safety for the subcutaneous injection (SC) formulation of 'Aptozma (development name: CT-P47),' a biosimilar of the autoimmune disease treatment 'Actemra (active ingredient: tocilizumab)'.

Based on the results of the global phase 3 clinical trial, Celltrion applied for domestic product approval for the Aptozma 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 to obtain approval for the intravenous (IV) formulation of Aptozma in Korea.

On this day, Celltrion also obtained approval for the 80 mg/4 ml dose of Aptozma IV formulation, thereby securing the entire lineup of doses of the original product's IV formulation, including the already approved 200 mg/10 ml and 400 mg/20 ml doses.

Celltrion expects that by adding the SC formulation of Aptosma and securing additional capacity for the IV formulation, it will expand treatment options for medical professionals considering the patient's condition and convenience, thereby significantly enhancing its competitiveness in the domestic tocilizumab market.

Actemra, the original drug of Aptosma, is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation in the body. Last year, it recorded global sales of approximately 2.645 billion francs (approximately 4 trillion won).

Celltrion’s strategy to conquer the global tocilizumab market, including the United States, the world’s largest pharmaceutical market, is progressing smoothly. Last year, it received a recommendation for approval of the product from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), and is awaiting final approval. Last month, it also received approval for both IV and SC formulations of Aptozuma from the U.S. Food and Drug Administration (FDA), making its entry into the global market more visible.

Celltrion plans to further strengthen its position in the global autoimmune disease treatment market based on a solid product line of five autoimmune disease drugs, ranging from tumor necrosis factor alpha (TNF-α) inhibitors such as Remsima, Remsima SC (US brand name Zimpentra), and Uplyma to interleukin (IL) inhibitors such as Stekima and Aptozma.

In particular, the interleukin inhibitor product line is expected to see sales growth due to portfolio synergy effects, as Stekima was recently launched in major global countries including Europe, and Aptozma is about to be launched.

A Celltrion official said, “Following the approval in the U.S. for both the Aptozma IV and SC formulations in Korea, we have strengthened our autoimmune disease portfolio.” He added, “We expect synergy among the five products that can provide the optimal treatment option for patients with autoimmune diseases, so we will do our best to accelerate sales growth by proceeding with the remaining approval and commercialization procedures without a hitch.”

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