Celltrion Inc. received U.S. regulatory approval to begin late-stage trials of its biosimilar version of Johnson & Johnson’s blockbuster cancer drug Darzalex, advancing its push into the lucrative blood cancer market.
The South Korean pharmaceutical company plans to enroll 486 patients with refractory or relapsed multiple myeloma in its Phase 3 study of CT-P44. The trial aims to match the original drug’s effectiveness in treating the bone marrow cancer that affects plasma cells.
The move positions Celltrion to compete in a market worth 12.7 trillion won ($9.7 billion) annually when Darzalex’s U.S. patent expires in 2029. The company already markets three cancer biosimilars globally, including Truxima for blood cancers and Herzuma for breast and gastric malignancies.
Celltrion is expanding its oncology portfolio beyond simple biosimilars. The company is developing antibody-drug conjugates for solid tumors and recently gained FDA clearance to test a copycat version of Merck & Co.’s immunotherapy Keytruda.
The approval marks Celltrion’s latest effort to challenge major pharmaceutical companies by offering cheaper versions of expensive biologic drugs as patents expire.
