South Korea’s Celltrion has submitted an investigational new drug application to the U.S. Food and Drug Administration (FDA) to conduct Phase 3 clinical trials for its biosimilar of Amgen’s osteoporosis drug Prolia.

The company has conducted a Phase 1 trial of CT-P41 since August last year. Biosimilars usually skip Phase 2 trials because the administration and dosage have already been established by the reference drug.

The Phase 3 study is designed to enroll 416 patients in five countries with a goal of completion by the first half of 2024. The company aims to evaluate the safety and efficacy profile of CT-P41 in the clinical trial, and plants to go commercial in February 2025 when Prolia becomes off-patent.

Prolia is indicated for the treatment of postmenopausal women with osteoporosis and bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer. Amgen reported nearly $3 billion in sales from the drug in 2019.

Celltrion expects a high revenue contribution from a pipeline of CT-P41 and other investigational biosimilars in reference to blockbuster therapies such as Humira, Avastin, Xolair, and Stelara.

The company said it plans to speed up the ongoing global clinical trials and continue to provide high-quality and affordable biopharmaceuticals to the world.

By Kim Byung-ho and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]