Celltrion has announced the launch of AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in the United States.
The US Food and Drug Administration (FDA) approved AVTOZMA IV to treat the same conditions as its 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).
AVTOZMA IV will be available in the same presentations as Actemra IV: 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.
Thomas Nusbickel, Chief Commercial Officer of Celltrion USA, said, "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 US healthcare system.”
"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,” he added.
AVTOZMA received approval from the US FDA in January 2025 and the European Commission in February 2025. This marks Celltrion’s fifth immunology biologic and seventh FDA-approved biosimilar.
Celltrion’s other FDA-approved biosimilars include: INFLECTRA (infliximab-dyyb), TRUXIMA (rituximab-abbs), HERZUMA (trastuzumab-pkrb), VEGZELMA (bevacizumab-adcd), YUFLYMA (adalimumab-aaty), STEQEYMA (ustekinumab-stba), STOBOCLO (denosumab-bmwo), OSENVELT (denosumab-bmwo), and OMLYCLO (omalizumab-igec), along with the novel biologic ZYMFENTRA (infliximab-dyyb).
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