On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab). The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®. Celltrion announced that it will use these results to accelerate applications for product approvals in other countries.
This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47. On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.