Celltrion said it obtained product approval from the Ministry of Food and Drug Safety (MFDS) for the subcutaneous (SC) formulation of Avtozma, a biosimilar referencing Actemra (ingredient: tocilizumab), for the treatment of autoimmune diseases.

Actemra, initially developed by Osaka University and Chugai Pharmaceutical and licensed in 2003 by Roche, is an interleukin-6 (IL-6) inhibitor that reduces inflammation by targeting the IL-6 protein. In 2023, Actemra generated about 2.63 billion Swiss francs (4.2 trillion won) in global sales. The U.S. market contributed $1.6 billion, accounting for more than half of the total revenue.

The Korean regulator approved the SC form based on the results of a global phase 3 clinical trial. This follows the company’s achievement last year of obtaining the first Korean approval for the intravenous (IV) formulation of an Actemra biosimilar.

Celltrion also announced that it expanded its IV formulation offerings with the approval of an 80mg/4ml dosage, complementing the previously approved 200mg/10ml and 400mg/20ml dosages.

With these approvals, Celltrion now offers the full range of IV formulation dosages available for the original Actemra product.

Celltrion expects that the addition of the SC formulation and expanded IV dosage options will enhance treatment flexibility for healthcare professionals and improve patient convenience, thereby strengthening Celltrion’s competitiveness in the Korean tocilizumab market.

Celltrion is making significant strides in its global expansion of the tocilizumab biosimilar market, including the world’s largest pharmaceutical market, the United States.

In Europe, Avtozma received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) last year, with final approval anticipated soon. The company has also received approval from the U.S. Food and Drug Administration (FDA) granted approval for both the IV and SC formulations of AVTOZMA in January.

“With Avtozma IV and SC now approved in both Korea and the U.S., we have further strengthened our autoimmune disease portfolio,” a company official said. “The synergy among our five autoimmune disease treatments is expected to provide optimal therapeutic options for patients.”

The company will ensure that all remaining approval and commercialization processes proceed smoothly to accelerate revenue growth, he added.