Celltrion's headquarters in Yeonsu-gu, Incheon (Celltrion)

South Korean biopharmaceutical firm Celltrion said Monday it has submitted an investigational new drug application to the US Food and Drug Administration for a Phase 3 clinical trial of CT-P44, its new biosimilar candidate referencing Darzalex.

Darzalex, a targeted cancer therapy, inhibits the growth of myeloma cells by binding to specific surface proteins. The Phase 3 trial will evaluate the pharmacokinetics, efficacy and safety of CT-P44 compared to Darzalex in 486 patients with relapsed or refractory multiple myeloma, according to the company.

The original drug generated $9.74 billion in global sales last year, with its US and European patents set to expire in 2029 and 2031, respectively. The company also filed a request for regulatory approval through the Clinical Trials Information System in Europe, the firm said.

CT-P44 adds to Celltrion's existing lineup of targeted cancer therapies, including Truxima for blood cancers, Herzuma for breast and gastric cancers, and Vegzelma for metastatic colorectal cancer -- flagship products the firm is leveraging to grow its market share.

Celltrion also recently secured FDA approval for a Phase 3 trial of its Keytruda biosimilar candidate, CT-P51, adding to its efforts for new therapies, including CT-P70 and CT-P71, antibody-drug conjugates targeting solid tumors.

“With the IND submission of CT-P44 in Europe and now the US, the world’s largest oncology market, we are fully committed to advancing CT-P44’s Phase 3 trial," said a Celltrion official.

"From targeted therapies to immuno-oncology and antibody-drug conjugates, we are building a robust oncology portfolio to secure competitiveness and expand our pipeline.”

By Hwang Joo-young (flylikekite@heraldcorp.com)