Celltrion said Thursday that it has initiated phase 3 clinical trial procedures for CT-P44, its biosimilar to Janssen' Darzalex (daratumumab), a treatment for multiple myeloma.

The company recently submitted an investigational new drug (IND) application for the global phase 3 trial to the European Medicines Agency's Clinical Trials Information System (CTIS). The trial will involve 486 patients with refractory and relapsed multiple myeloma, comparing the efficacy and safety of Darzalex and CT-P44.

Darzalex, a monoclonal antibody that targets and inhibits the growth of multiple myeloma cells, generated $9.74 billion in global sales last year. The drug is set to lose patent protection in the U.S. and Europe in 2029 and 2031, respectively.

CT-P44 is a key component of Celltrion’s expanding oncology biosimilar portfolio. The company plans to file INDs in additional markets, including the U.S. and Korea, to advance global clinical trials.

Celltrion is also developing next-generation cancer treatments, including antibody-drug conjugates (ADCs) CT-P70 and CT-P71, aimed at solid tumors such as non-small cell lung cancer (NSCLC) and bladder cancer. The company’s existing oncology biosimilars—Truxima (rituximab), Herzuma (trastuzumab), and Vegzelma (bevacizumab)—have already established a strong market presence.

Celltrion received FDA approval in August for a phase 3 trial of CT-P51, a biosimilar to Keytruda (pembrolizumab), further accelerating its entry into immuno-oncology.

“Now that CT-P44 has entered full-scale clinical trials, we plan to leverage our expertise in developing antibody-based anticancer drugs to accelerate progress,” a Celltrion official said. “We are committed to building a robust portfolio, from targeted therapies to immuno-oncology drugs and ADCs, while securing future pipelines.”