Celltrion announced on September 1 that it has received approval from the European Medicines Agency (EMA) for its global Phase 3 clinical trial plan for 'CT-P44,' a biosimilar (biopharmaceutical generic) of Darzalex (active ingredient: daratumumab), a treatment for multiple myeloma, a type of blood cancer.
Celltrion plans to demonstrate similarity between Darzalex and CT-P44 through an efficacy and safety comparison study involving a total of 486 patients with refractory and relapsed multiple myeloma over a two-year period.
Darzalex is a targeted anticancer drug that binds to a specific protein present on the surface of multiple myeloma cells, blocking the growth of cancer cells. In 2023, its global sales reached approximately 9.744 billion dollars (about 13.5694 trillion won), and its substance patents are set to expire in the United States in 2029 and in Europe in 2031.
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