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.
Pharming receives FDA priority review for leniolisib in children with APDS
Renalytix submits CE Mark application for kidneyIntelX.dkd in Europe
Vicore Pharma's buloxibutid receives orphan drug designation in Japan
Novartis to launch US direct-to-patient platform for Cosentyx
Genmab to acquire Merus in USD8bn all-cash deal
Polarean Imaging signs new supply agreementwith UVA Health for clinical Xenon MRI
Genmab to acquire Merus in USD8bn deal to strengthen oncology pipeline
Sen-Jam Pharmaceutical and KVK Tech complete final development deliverables for SJP-002C