Celltrion’s Avtozma Receives FDA Approval as Biosimilar to Actemra
Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved its biosimilar product, Avtozma® (CT-P47, tocilizumab-anoh), available in both intravenous (IV) and subcutaneous (SC) formulations. The approval marks an important milestone in Celltrion’s efforts to expand accessible treatment options for patients suffering from a range of inflammatory conditions, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and coronavirus disease (COVID-19).
“Introducing both IV and SC formulations of Avtozma provides flexibility and a wider range of treatment options,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs.”
The FDA’s decision was supported by a comprehensive data package and the totality of evidence, including results from a pivotal Phase III study. The trial, conducted in patients with moderate to severe active RA, demonstrated that Avtozma is highly similar to its reference product, tocilizumab. The study met its primary endpoint by showing comparable change from baseline in the disease activity score using 28 joints (DAS28)-ESR at Week 24, with one-year follow-up data further affirming the biosimilarity in terms of efficacy, pharmacokinetics, safety, and immunogenicity.
Avtozma is designed to match the reference product’s formulation and dosages. The IV infusion is available in 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL) doses, while the SC injection comes in a single-dose prefilled syringe or autoinjector containing 162 mg/0.9 mL. This dual formulation approach is expected to enhance patient convenience and treatment adherence.
This FDA approval marks Celltrion’s seventh biosimilar to receive marketing authorization in the United States, underscoring the company’s growing influence in the biopharmaceutical market and its ongoing commitment to providing high-quality biosimilar alternatives.
About Avtozma® (tocilizumab-anoh):
Avtozma® contains tocilizumab, a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. The drug was evaluated in a global Phase III clinical trial that compared its efficacy, pharmacokinetics (PK), safety, and immunogenicity with those of the reference tocilizumab.
Following its submission for regulatory approval with the FDA in January 2024—and with a similar filing made with the European Medicines Agency (EMA) in February 2024—Avtozma has now secured approval in the U.S., further cementing its role as a robust treatment option for a range of inflammatory conditions.