Celltrion has obtained the U.S. Food and Drug Administration’s approval for Avtozma, its Actemra (ingredient: tocilizumab) biosimilar, for subcutaneous (SC) and intravenous (IV) formulations.

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 approval allows Avtozma to be prescribed for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and Covid-19.

Celltrion filed for FDA approval last year based on global phase 3 clinical trial results.

Before receiving FDA approval, Celltrion had already obtained local approval for Avtozma last December as the first biosimilar for Actemra, positioning itself as a first mover.

The company has also received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), paving the way for final authorization in the European market.

With the FDA approval, Celltrion aims to establish a stable supply chain in the U.S. while leveraging a competitive pricing strategy and high-quality products to expand its market share rapidly.

“The FDA approval in the world’s largest pharmaceutical market allows us to expedite the remaining commercialization processes and strengthen our presence in the global autoimmune disease treatment sector,” a Celltrion representative stated. “We will do our utmost to ensure a stable and rapid supply of this treatment to patients in need.”

Celltrion has been expanding its biosimilar pipeline, aligning with its strategic goal of building an 11-product portfolio by 2025. The company aims to broaden its presence further by developing 22 biosimilars by 2030.