Celltrion said that it has submitted an investigational new drug (IND) application for its phase 3 clinical trial of CT-P41, a Prolia biosimilar, to the U.S. Food and Drug Administration.

Celltrion has submitted its IND application to start phase 3 clinical trial into a biosimilar for Prolia to the U.S. FDA. (Celltrion)
Celltrion has submitted its IND application to start phase 3 clinical trial into a biosimilar for Prolia to the U.S. FDA. (Celltrion)

The IND application comes after the company has been conducting a phase 1 clinical trial of CT-P41 since August of last year. The company will recruit 416 patients from a total of five countries for its phase 3 clinical trial.

Celltrion plans to complete the trial by the first half of 2024 and commercialize the treatment by February 2025, when Prolia's U.S. substance patent expires.

Prolia, developed by Amgen, is a monoclonal antibody injection that targets receptor activator of nuclear factor kappa-B ligand (RANKL) proteins in osteoporosis patients. According to Amgen's annual report, the drug's sales reached 3.2 trillion won ($2.6 billion) in 2019.

Celltrion expects that CT-P41 will become the firm's future growth driver as well as CT-P17, a Humira biosimilar currently undergoing review by the European Medicines Agency, CT-P16 (Avastin biosimilar), CT-P39 (Xolair biosimilar), and CT-P43 (Stelara biosimilar).

"In line with Celltrion Group's 2030 vision, which aims to receive approval for one or more products annually until then, the company will speed up its global clinical trials for CT-P41," a company official said. "We plan to continuously supply high-quality biopharmaceuticals at reasonable prices to the world by successfully conducting phase 3 clinical trials in the U.S."

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