Celltrion has secured approval from the Ministry of Food and Drug Safety (MFDS) in Korea for the subcutaneous (SC) formulation of Avtozma, a biosimilar referencing Actemra (tocilizumab), used in treating autoimmune diseases. This approval follows the previous authorization of the intravenous (IV) formulation of Avtozma in Korea, marking a significant expansion of Celltrion's offerings in the tocilizumab market.
The Korean regulator's decision was based on the results of a global Phase 3 clinical trial. Actemra, originally developed by Osaka University and Chugai Pharmaceutical and licensed by Roche in 2003, functions as an interleukin-6 (IL-6) inhibitor, reducing inflammation by targeting the IL-6 protein. In 2023, Actemra generated approximately 2.63 billion Swiss francs (4.2 trillion won) in global sales, with the U.S. market contributing $1.6 billion, more than half of the total revenue.
Expanded Dosage Options
Celltrion also announced the approval of an 80mg/4ml dosage for its IV formulation of Avtozma, complementing the existing 200mg/10ml and 400mg/20ml dosages. This expansion ensures that Celltrion now offers the full range of IV formulation dosages available for the original Actemra product.
Strategic Implications
Celltrion anticipates that the addition of the SC formulation and the expanded IV dosage options will provide healthcare professionals with enhanced treatment flexibility and improve patient convenience. This is expected to strengthen Celltrion’s competitiveness in the Korean tocilizumab market and support its global expansion efforts.
Global Expansion
Celltrion is actively pursuing global expansion in the tocilizumab biosimilar market, including the United States, the world’s largest pharmaceutical market. 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 U.S. Food and Drug Administration (FDA) granted approval for both the IV and SC formulations of AVTOZMA in January.
Company Perspective
"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 stated. "The synergy among our five autoimmune disease treatments is expected to provide optimal therapeutic options for patients." The company is focused on ensuring that all remaining approval and commercialization processes proceed smoothly to accelerate revenue growth.
