Celltrion Applies for US Approval of Prolia Biosimilar 'CT-P41'

Osteoporosis Treatment Biosimilar
Application for Approval Covering All Original Indications
"Rapid Market Penetration Expected"

Celltrion announced on the 1st that it completed the application for marketing authorization of the osteoporosis treatment biosimilar 'CT-P41' (active ingredient denosumab), a biosimilar of 'Prolia-Xgeva,' to the U.S. Food and Drug Administration (FDA) on the 30th of last month (local time).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Based on the global Phase 3 clinical trial results of CT-P41, Celltrion applied for marketing authorization covering all indications held by the original products Prolia and Xgeva in the United States. The indications held by the original products include ▲osteoporosis ▲bone loss ▲prevention of skeletal-related complications due to bone metastases from multiple myeloma and solid tumors ▲giant cell tumor of bone, among others.

The company plans to sequentially apply for approvals in major global markets such as Europe following the U.S. application.

In October, Celltrion conducted a global Phase 3 clinical trial involving 477 postmenopausal women with osteoporosis in four countries, including Poland and Estonia, confirming equivalence and pharmacodynamic similarity compared to the original drug.

From the development stage, Celltrion consulted with the FDA and the European Medicines Agency (EMA) to design a global development program based on the global Phase 3 clinical trial results, enabling CT-P41 to be approved simultaneously as a biosimilar to both Prolia and Xgeva. Once CT-P41 is approved in the U.S., it is expected to secure the status of an interchangeable biosimilar, allowing substitution prescriptions for the original products. Celltrion expects this to facilitate rapid market penetration and improve patient accessibility.

Prolia is an osteoporosis treatment drug by the multinational pharmaceutical company Amgen, with the same active ingredient approved under the product name 'Xgeva' for preventing and treating bone metastasis complications in cancer patients. According to IQVIA, it recorded sales of $5.83 billion (approximately 7.54 trillion KRW) last year, and its patents are set to expire in the U.S. and Europe in February and November 2025, respectively.

A Celltrion official stated, "We confirmed equivalence and similarity to the original drug in the Phase 3 clinical trial of CT-P41 and have completed the application for marketing authorization as a biosimilar eligible for substitution in the U.S. We will proceed smoothly with the remaining approval processes through consultations with regulatory authorities and do our best to rapidly expand our market influence in the field of bone disease treatments."

Meanwhile, Celltrion aims to have a portfolio of 11 biosimilar products, including CT-P41, by early 2025. Through this, the company expects to maximize synergy effects in the distribution process and create a positive impact on global market sales.