On December 15, Celltrion announced global Phase 3 results for CT-P47, a biosimilar to Actemra (tocilizumab) for the treatment of rheumatoid arthritis.
The Phase 3 study was conducted in 471 patients with rheumatoid arthritis (RA) and lasted 52 weeks after the first dose, and these results are up to week 32.
The primary endpoint was the change in Disease Activity Score (DAS) 28 values from baseline, a key marker of RA activity, in two groups: those receiving CT-P47 and those receiving the original drug. DAS 28 is a disease activity score based on a 28-joint count.
The results showed that the difference between the originator and CT-P47 arms met the predefined equivalence criteria. Similar results were seen for secondary endpoints assessing efficacy, pharmacokinetics, and safety in three groups: the CT-P47 arm, the originator arm, and the CT-P47 switch to originator starting at week 24.
Based on the Phase 3 results, Celltrion plans to file for authorization with key national regulatory agencies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea, as soon as possible.
Actemra is a blockbuster autoimmune disease treatment with global sales of approximately KRW 4.05 trillion (CHF 2.71 billion) last year and is used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.
Actemra is an interleukin that reduces inflammation by inhibiting the interleukin (IL) 6 protein, which is involved in causing inflammation in the body, and is available in two formulations: subcutaneous administration (SC) and intravenous injection (IV). Like the original drug, Celltrion's CT-P47 is being developed in both SC and IV formulations to give healthcare providers the option to prescribe based on patient condition and convenience.
"CT-P47 confirmed equivalence and similarity to the original drug in global Phase 3 clinical results," said an official of Celltrion. "Based on these results, we are committed to accelerating our global license application and expanding our autoimmune disease portfolio with interleukin inhibitors after tumor necrosis factor alpha (TNF-α) inhibitors such as Remsima and Yuflyma."
Meanwhile, Celltrion plans to launch five new biosimilar pipelines, including an Actemra biosimilar, starting next year, to complete a portfolio of 11 products by 2025.
