Celltrion announced on the 13th that it has received item approval from the Ministry of Food and Drug Safety for the subcutaneous injection (SC) formulation of ACTEMRA (tocilizumab), a treatment for autoimmune diseases, as a biosimilar.
According to Celltrion, the SC formulation of the ACTEMRA biosimilar 'AVTOZMA' has been approved for use in rheumatoid arthritis (RA). Last year, it was the first in South Korea to obtain approval for the intravenous (IV) formulation of AVTOZMA.
On that day, Celltrion also received approval for the low-dose IV formulation of AVTOZMA at 80 mg/4 mL. It has secured all dosage groups of the IV formulation held by the original drug, including 200 mg/10 mL and 400 mg/20 mL. The company expects that the widened treatment options, considering patient conditions and convenience, will enhance its competitiveness in the domestic tocilizumab market.
The original drug AVTEMRA, which AVTOZMA is based on, is an interleukin inhibitor that reduces inflammation by suppressing interleukin (IL)-6 proteins, which are involved in triggering inflammation. Last year, its global sales reached approximately 2.645 billion Swiss francs (about 4 trillion won).
Celltrion is also targeting the global tocilizumab market, including the United States. Last year, AVTOZMA received a positive recommendation for item approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), and last month it obtained all necessary approvals for the AVTOZMA IV and SC formulations from the U.S. Food and Drug Administration (FDA).
A Celltrion official noted, "Following the United States, we have obtained approvals for both the AVTOZMA IV and SC formulations in South Korea, strengthening our autoimmune disease portfolio." He added, "As synergy is expected among the five products that can provide optimal treatment options for autoimmune disease patients, the remaining approval and commercialization procedures will proceed smoothly."