Celltrion announced on the 1st that it has received approval from the European Medicines Agency for the global Phase 3 clinical trial plan for the biosimilar, 'CT-P44' (active ingredient: daratumumab). Darzalex is a treatment for multiple myeloma, a type of blood cancer.
Celltrion will conduct a trial over two years comparing the efficacy and safety of Darzalex and CT-P44 in 486 patients with multiple myeloma. The plan is to demonstrate similarity through this trial.
Darzalex is a targeted anticancer drug that binds to a specific protein present on the surface of multiple myeloma cells, blocking cancer cell growth. Global sales in 2023 are expected to reach approximately $9.744 billion (12.67 trillion won). The material patents will expire in the U.S. and Europe in 2029 and 2031, respectively.