Incheon Songdo Celltrion headquarters. /Courtesy of Celltrion

Celltrion announced on the 31st that its autoimmune disease treatment 'Avtozma' has received product approval from the U.S. Food and Drug Administration (FDA). The development name of Avtozma is CT-P47.

Avtozma has been developed as a biosimilar to the global pharmaceutical company Roche's 'Actemra' (ingredient name tocilizumab), and this approval has opened the path for sales in the U.S. market.

Based on global phase 3 clinical results, Celltrion applied for U.S. product approval for Avtozma last year, securing approval 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).

As the original drug Actemra was launched in two formulations, subcutaneous (SC) and intravenous (IV), Avtozma has also been approved in both formulations to allow healthcare providers to prescribe selectively based on the patient's condition and convenience.

Actemra is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation. In 2023, it recorded global sales of approximately 2.63 billion Swiss francs (about 4 trillion won). Notably, in the U.S. market alone, it generated more than half of its total sales, amounting to $1.638 billion (about 2.2932 trillion won).

Avtozma obtained approval in South Korea last month, making it the first Actemra biosimilar to receive such approval. It has also recently received a recommendation for product approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is in the final stages of the approval process.

A company official noted, "With the approval in the U.S., the largest pharmaceutical market in the world, we plan to quickly complete the remaining commercialization procedures and proactively enter the global autoimmune disease treatment market." Celltrion aims to build a portfolio of 22 biosimilars by 2030 and strengthen its dominance in the global market.