Celltrion secures FDA nod for Actemra biosimilar Avtozma
Celltrion announced on Friday that its biosimilar Avtozma, a version of the autoimmune disease treatment Actemra (active ingredient tocilizumab), has received product approval from the US Food and Drug Administration.
Based on the results of its global Phase 3 clinical trial, Celltrion applied for Avtozma's FDA approval last year. The approval covers major indications, including rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and COVID-19 infection.
The original drug, Actemra, is available in two formulations: subcutaneous injection and intravenous injection. Celltrion has secured FDA approval for Avtozma in both formulations, allowing healthcare providers to prescribe the most suitable option based on patient needs.
Actemra is an interleukin-6 inhibitor that works by suppressing the IL-6 protein, which is involved in inflammation, thereby reducing inflammation in the body. In 2023, the drug recorded global sales of some 2.63 billion Swiss francs ($2.89 billion).
In the US market alone, Actemra generated $1.638 billion in revenue, accounting for more than half of its global sales, making the US the most significant market.
Prior to US approval, Celltrion became the first company in Korea to obtain domestic approval for Avtozma last month, establishing itself as a first mover in the Actemra biosimilar market.
Additionally, the company recently received a positive opinion for approval from the Committee for Medicinal Products for Human Use under the European Medicines Agency, moving a step closer to final authorization in Europe.
With the FDA approval, Celltrion plans to establish a stable supply chain in the US and expand its market share through competitive pricing strategies and high-quality products. Avtozma is expected to offer an economical treatment alternative while maintaining efficacy and safety equivalent to the original drug, ultimately benefiting both patients and healthcare providers in the US.
"Receiving FDA approval in the world's largest pharmaceutical market allows us to swiftly complete the remaining commercialization process and fully launch our strategy to penetrate the global autoimmune disease treatment market," a Celltrion official said. "We are committed to ensuring a faster and more stable supply of treatments for patients."
With Avtozma's winning of domestic approval, Celltrion has achieved its goal to build an 11-biosimilar product lineup earlier than the initially planned target of the end of 2025. The drugmaker aims to expand its biosimilar portfolio to 22 products by 2030.
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