Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA approval for Tofidence®, its biosimilar Actemra® on 30 September 2023. On 1 August 2022 the FDA accepted Fresenius Kabi’s BLA for its tocilizumab biosimilar.
On 14 December 2023, Celltrion revealed that its phase III clinical trial of CT-P47 demonstrated equivalence with Actemra® in patients with rheumatoid arthritis.