Celltrion 'Aptozuma' Phase 3 Efficacy Published in International Journal

[Financial News] Celltrion announced on the 16th that the global Phase 3 52-week results of the rheumatoid arthritis (RA) treatment 'Actemra (ingredient name: Tocilizumab)' biosimilar 'Aptozuma (development name CT-P47)' have been published in the international journal 'Clinical Drug Investigation'. The study published this time contains the 52-week results of Phase 3 evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of the CT-P47 intravenous (IV) formulation conducted on 471 patients with rheumatoid arthritis.
The clinical trial was conducted by dividing into an initial CT-P47 administration group and an original drug administration group, and from the 24th week, the original drug administration group was randomly assigned to a maintenance administration group and a switch administration group converted to CT-P47, and a total of three groups were compared and evaluated.
As a result, the main indicators including efficacy, pharmacokinetics, safety, and immunogenicity were found to be at similar levels in all groups: the group continuously administered CT-P47, the group maintained on the original drug, and the switch administration group converted to CT-P47. This confirmed that CT-P47 can be a stable treatment option even in long-term treatment and switching situations.
The original drug of Aptozuma, Actemra, is an interleukin (IL)-6 inhibitor that reduces inflammation by inhibiting the IL-6 protein involved in causing inflammation in the body, and recorded global sales of approximately 2.645 billion francs (about 4 trillion won) last year.
Celltrion, after obtaining domestic approval for Aptozuma at the end of last year, has been accelerating its global market strategy by obtaining consecutive product approvals in the United States and Europe early this year.
A Celltrion official stated, "It is significant that we can announce through this publication that both the efficacy and safety of Aptozuma have been confirmed even in long-term treatment and switching situations," and added, "Based on the published data, we plan to accelerate the expansion of prescriptions and market share in the global market."

vrdw88@fnnews.com Kang Jung-mo Reporter