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.
LEO Pharma advances delgocitinib cream into phase 3 trial for lichen sclerosus
HistoIndex partners Houston Research Institute
Formosa Pharmaceuticals licenses APP13007 ophthalmic therapy to Samil for South Korea
Bambusa Therapeutics reports first patient dosed in proof-of-concept COPD trial
Elanco Animal Health's Befrena (tirnovetmab) receives USDA approval for canine dermatitis
Sanofi and Regeneron's Dupixent gains Japan approval for paediatric asthma patients aged 6 to 11
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
Alvotech launches first-in-market golimumab biosimilar in Europe
Physiomics secures follow-on UK contract for Phase 2 study support
RedHill Biopharma reports positive opaganib data in venetoclax-resistant CLL
InduPro secures strategic investment and collaboration with Sanofi to advance autoimmune therapy
Innovent Biologics reports first participant dosed in Phase 1 trial of IBI3011