• The AVTOZMA^® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA^® (tocilizumab)
• AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA
• This launch strengthens Celltrion's immunology portfolio beyond tumor-necrosis factor (TNF)-alpha and interleukin (IL)-12 and 23 inhibitors, to include an IL-6 inhibitor, broadening coverage across multiple inflammatory pathways and addressing a wider spectrum of diseases and patient populations

Celltrion, Inc.announced that AVTOZMA^® (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States.

AVTOZMA IV is approved for all same indications as the reference product Actemra^®  (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (COVID-19) and cytokine release syndrome (CRS).^[1] AVTOZMA IV will be available in all the same formulations currently provided by ACTEMRA IV. The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in 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."

At launch, AVTOZMA IV will be supported by a comprehensive patient support resources for healthcare providers and patients, and copay support for eligible commercial patients prescribed AVTOZMA IV.