On October 2, 2025, Celltrion, Inc. (“Celltrion”) announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States. AVTOZMA® is supplied as an intravenous formulation in single-dose vials in the same doses as ACTEMRA®: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. It is…
On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in patients aged 2 years and older. CRS is a potentially life-threatening condition brought on by a so-called “cytokine storm”…
On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®. Tocilizumab is a monoclonal antibody that acts as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The EC approved AVTOZMA® for all indications of the reference product, including moderate…
On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®. Tocilizumab is a monoclonal antibody that can act as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The FDA approved AVTOZMA® for subcutaneous injection or intravenous infusion for treatment of…