Actemra Biosimilar 'CT-P47'
First Clinical Data Revealed at European Rheumatology Congress
"Will Accelerate Entry into Tocilizumab Market"
Celltrion announced on the 31st that it has publicly disclosed online for the first time the domestic Phase 1 clinical data of CT-P47, a biosimilar of the rheumatoid arthritis treatment Actemra (generic name: tocilizumab), at the '2023 European League Against Rheumatism (EULAR 2023)'.
The European League Against Rheumatism (EULAR) is one of the world's most prestigious rheumatic disease societies. Through its annual scientific meeting, it presents the latest clinical results, trends in therapeutic development, and conducts related discussions. This year, the event is scheduled to take place in Milan, Italy, from May 31 to June 3.
Celltrion conducted a Phase 1 clinical trial involving 318 healthy subjects in South Korea. The subjects were divided into two groups: one receiving subcutaneous injections of CT-P47 and the other receiving subcutaneous injections of the original drug. Following a single dose, CT-P47 demonstrated pharmacokinetic (PK) equivalence compared to the original drug. In terms of safety, the CT-P47 subcutaneous injection group showed results similar to those of the original drug.
Since July of last year, Celltrion has also been conducting a global Phase 3 clinical trial of CT-P47 involving a total of 448 rheumatoid arthritis patients in Europe. Additionally, to allow healthcare providers to select prescriptions based on patient condition and convenience, CT-P47 is being developed in two formulations?subcutaneous injection (SC) and intravenous injection (IV)?just like the original drug.
Actemra, developed by the global pharmaceutical company Roche, is an interleukin inhibitor that reduces inflammation by suppressing interleukin-6 protein involved in triggering inflammation in the body. It is indicated for rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. Actemra recorded global sales of approximately KRW 4.53 trillion (2.71 billion Swiss francs) last year.
A Celltrion official stated, "We have confirmed the pharmacokinetic equivalence and safety of CT-P47 in Phase 1 clinical trials and have publicly disclosed the clinical results for the first time at the prestigious European League Against Rheumatism. We will continue to proceed smoothly with the ongoing Phase 3 clinical trials and do our best to expand our portfolio as an interleukin inhibitor biosimilar following TNF-alpha (α) inhibitors."
At EULAR 2023, the Celltrion Group plans to open a standalone promotional booth to introduce the competitiveness of products such as Remsima SC and Uplyma, which are currently supplied locally in Europe.
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