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Celltrion Submits BLA for CT-P47, Biosimilar to Genentech’s Actemra® (tocilizumab)

Jan 28, 2024

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.