Celltrion Applies for Domestic Approval of 'CT-P41', a Biosimilar of 'Prolia', Following US Submission

Celltrion announced on the 29th that it has completed the application for marketing authorization of the biosimilar ‘CT-P41’ of the osteoporosis treatment ‘Prolia-Xgeva (active ingredient denosumab)’ to the Ministry of Food and Drug Safety.

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

Prolia is an osteoporosis treatment developed by the multinational pharmaceutical company Amgen. A drug for the prevention and treatment of bone metastasis complications in cancer patients using the same active ingredient is marketed as 'Xgeva.' According to IQVIA, it recorded sales of $5.83 billion (approximately KRW 7.4859 trillion) last year, and its patents are expected to expire in the US and Europe in February and November 2025, respectively.

Celltrion applied for marketing authorization covering the full label indications held domestically by the original products Prolia and Xgeva, including osteoporosis, bone loss, prevention of skeletal-related complications due to multiple myeloma and solid tumor bone metastases, and giant cell tumor of bone. Earlier, on the 30th of last month (local time), it also applied for marketing authorization for all indications of the original drugs to the US Food and Drug Administration (FDA). The company plans to sequentially proceed with approvals in major countries worldwide such as Europe and Canada to accelerate its global market entry.

Amgen's osteoporosis treatment 'Prolia'
Photo by Amgen

This application was based on the results of a global Phase 3 clinical trial of CT-P41 conducted on 477 postmenopausal women with osteoporosis in four European countries including Poland and Estonia.

Celltrion evaluated the change in lumbar spine bone mineral density from baseline as the primary endpoint in both the CT-P41 treatment group and the original drug treatment group. The evaluation results showed that the difference between the original drug and the CT-P41 group fell within the pre-defined equivalence margin, demonstrating equivalence. Secondary endpoints, including key bone metabolism markers 's-CTX' and 'P1NP,' also showed similar trends between the original drug and CT-P41, confirming pharmacodynamic similarity.

Regarding safety, the incidence rates of adverse reactions and serious adverse reactions after administration were similar between the original drug group and the CT-P41 group, and no significant differences were observed in other parameters.

A Celltrion official stated, “We have confirmed equivalence and similarity to the original drug in the Phase 3 clinical trial of CT-P41 and completed the application for marketing authorization to the Ministry of Food and Drug Safety. We will proceed smoothly with the remaining approval procedures through consultations with regulatory authorities and do our best to rapidly expand our market influence in the field of bone disease treatments in the future.”

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