INCHEON, South Korea — Celltrion has introduced AVTOZMA (tocilizumab-anoh) intravenous, its FDA-approved biosimilar to Actemra IV, now available to patients in the United States. The launch marks Celltrion’s seventh FDA-approved biosimilar and its first IL-6 inhibitor, broadening its immunology portfolio to address a wider range of immune-mediated diseases.
Approved for the same indications as the reference product, AVTOZMA IV can be used to treat rheumatoid arthritis, giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19. The product will be available in the same formulations as Actemra IV, including 80 mg, 200 mg and 400 mg single-dose vials.
“Immune-mediated conditions such as rheumatoid arthritis have profound impact on patients’ daily lives,” said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology, Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin, Germany. “The availability of a tocilizumab biosimilar gives physicians additional options to manage the disease and maintain continuity of care, which is a welcome news for both patients and clinicians.”
“The launch of AVTOZMA IV reinforces Celltrion’s strong commitment to providing physicians and patients with access to high-quality treatment options for serious immune-mediated diseases and to supporting the sustainability of the U.S. healthcare system,” said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. “It also strengthens our immunology portfolio, expanding beyond TNF-α and IL-12/23 inhibitors, now including an IL-6 inhibitor, broadening coverage across inflammatory pathways and enhancing our ability to address a broader range of patient needs.”
AVTOZMA is supported by a patient assistance program offering resources for providers and patients, as well as copay support for eligible commercially insured patients. The introduction strengthens Celltrion’s U.S. portfolio of immunology biologics, which now spans TNF-α, IL-12/23 and IL-6 inhibitors.
For more information, see Full Prescribing Information.
