Celltrion submits Phase 3 clinical trial plan for Darzalex biosimilar

Celltrion CI

Celltrion announced on Thursday that it had recently submitted a Phase 3 clinical trial plan for CT-P44, a biosimilar of Darzalex (daratumumab), to the European Medicines Agency’s Clinical Trials Information System. Darzalex is a treatment for multiple myeloma, a type of blood cancer.

The Phase 3 trial will involve 486 patients with relapsed or refractory multiple myeloma and aims to compare the efficacy and safety of CT-P44 with Darzalex.

Darzalex, a targeted cancer therapy that binds to specific proteins on the surface of multiple myeloma cells to inhibit tumor growth, generated $9.74 billion in global sales in 2023. The drug’s substance patent is set to expire in the United States in 2029 and in Europe in 2031.

CT-P44 is a key product in Celltrion’s oncology biosimilar pipeline. Following the European submission, the company plans to file investigational new drug applications in the United States, South Korea, and other major markets as part of its global clinical development strategy.

The company said that with CT-P44 entering clinical trials, it plans to leverage its extensive expertise in developing antibody-based cancer therapies to accelerate the process. It also aims to strengthen its portfolio in the cancer treatment field, including targeted therapies, immuno-oncology drugs, and ADC innovations, while continuing to develop additional pipelines to enhance competitiveness.