Celltrion receives FDA nod for phase 3 trial of Darzalex biosimilar

Celltrion said Friday that it has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application to proceed with the global phase 3 clinical trial of its biosimilar to Janssen Biotech’s Darzalex (daratumumab), CT-P44.

Darzalex is a targeted cancer therapy that binds to a protein on the surface of multiple myeloma cells to prevent cancer cell growth. In 2023, Darzalex generated global revenue of approximately $9.74 billion, with its patent set to expire in the U.S. in 2029 and in Europe in 2031.

With this approval, Celltrion plans to initiate the global phase 3 trial involving 486 patients with relapsed or refractory multiple myeloma. The trial aims to demonstrate the similarity in pharmacokinetics, efficacy, and safety between Darzalex and CT-P44.

Celltrion will also accelerate clinical trials in key global markets, including Europe, where the IND application has already been completed. 

"With the clinical approval of the new pipeline CT-P44 in the U.S., the world's largest cancer market, we are preparing to target the $12.7 trillion daratumumab market,” said a Celltrion official. “We will continue to focus on expanding our oncology antibody treatment portfolio, including three targeted cancer therapies already proven in the global market, as well as future immuno-oncology and antibody–drug conjugates (ADC) drugs." 

The company has already launched three targeted cancer therapies—Truxima (rituximab) for blood cancer, Herzuma (trastuzumab) for breast and gastric cancer, and Vegzelma (bevacizumab) for metastatic colorectal cancer—in key markets like the U.S., Europe, and Japan.