South Korea-based Celltrion, Inc., a global biopharmaceutical company, announced on Thursday that it has launched AVTOZMA (CT-P47, tocilizumab-anoh) intravenous formulation in the United States.
The product was approved by the US Food and Drug Administration in January 2025 for the same indications as the reference product Actemra (tocilizumab), a drug indicated for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19. An additional FDA indication for cytokine release syndrome was granted in July 2025.
AVTOZMA IV is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA. The launch expands the company's immunology portfolio beyond tumour necrosis factor-alpha and interleukin-12/23 inhibitors to include an interleukin-6 inhibitor.
The drug will be available in the same intravenous formulations as Actemra, including 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials.
AVTOZMA IV will be supported by patient assistance programs, including copay support for eligible commercial patients.
Henlius and Organon secure first US approval for pertuzumab biosimilar POHERDY
CHMP issues positive opinion for DAWNZERA in hereditary angioedema
Longeveron secures US patent for stem cell therapy targeting aging-related frailty
Zoetis announces EU approval for Portela to relieve osteoarthritis pain in cats
Johnson & Johnson reports durable two-year remission data for TREMFYA in Crohn's disease
Trellus Health signs contract with leading global CRO and expands clinical trial offerings
Genentech's Gazyva (obinutuzumab) receives US FDA approval to treat adults with lupus nephritis
AstraZeneca wins US FDA approval for Tezspire in chronic rhinosinusitis with nasal polyps