Celltrion announced on February 13 that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, a biosimilar to Actemra for the treatment of autoimmune diseases.
Celltrion has submitted a Marketing Authorization Application for the full label of Actemra's originator drug in Europe for Rheumatoid Arthritis (RA), Giant Cell Arteritis (GCA), Systemic Juvenile Idiopathic Arthritis (sJIA), Polyarticular Juvenile Idiopathic Arthritis (pJIA), Cytokine Release Syndrome (CRS), and COVID-19.
The filing is based on results from a global Phase 3 clinical trial of CT-P47. Celltrion confirmed equivalence and similarity to the originator drug in the Phase 3 study, which included 471 RA patients.
Celltrion completed the U.S. Food and Drug Administration (FDA) filing for CT-P47 last month, followed by the European filing, which paves the way for access to key global markets.
Based on the Phase 3 results, Celltrion plans to accelerate the approval process in the U.S. and Europe, as well as in other global markets such as Canada.
Global approval of CT-P47 will expand Celltrion's portfolio to include interleukin (IL) inhibitors in addition to its existing TNF-α inhibitors, strengthening its position in the global autoimmune disease therapeutics market.
Actemra is an IL inhibitor that reduces inflammation by inhibiting the IL-6 protein, which is involved in causing inflammation in the body, and had global sales of approximately $2.84 billion in 2022, according to pharmaceutical market research firm Icubia.
As Actemra is available in two formulations, subcutaneous injection (SC) and intravenous injection (IV), Celltrion plans to launch CT-P47 in both SC and IV formulations to give healthcare providers the option to prescribe based on patient condition and convenience.
