Celltrion's 'Prolia' Biosimilar 'CT-P41' Applies for Approval in Europe Following US and Korea

Celltrion announced on the 8th that it has completed the marketing authorization application for CT-P41, a biosimilar developed for the osteoporosis treatments Prolia and Xgeva (active ingredient denosumab), to the European Medicines Agency (EMA).

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

Prolia is an osteoporosis treatment developed by the multinational pharmaceutical company Amgen. Xgeva, which uses the same active ingredient denosumab, is also marketed as a preventive and therapeutic agent for bone metastasis complications in cancer patients. It recorded sales of $6.16 billion (approximately 8 trillion KRW) last year, and its patents are expected to expire in the US and Europe in February and November 2025, respectively.

Celltrion has applied for marketing authorization covering all indications held by the original products Prolia and Xgeva in Europe, including ▲osteoporosis ▲bone loss ▲prevention of skeletal-related complications in adults with progressive malignant tumors related to bone ▲giant cell tumor of bone. Previously, the marketing authorization applications submitted to the US Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety also covered the full indications of the original drugs.

The application was based on the global Phase 3 clinical trial results 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, proving 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.

Amgen's osteoporosis treatment 'Prolia'
[Photo by Amgen]

Celltrion expects that once CT-P41 obtains approval, its biosimilar product portfolio will expand from existing autoimmune disease treatments and anticancer drugs to include bone disease treatments, thereby increasing Celltrion’s market influence and accelerating growth in its core biosimilar business sector. The company stated, "Since last year, we have been smoothly progressing global approval applications for five new biosimilar pipelines including CT-P41," adding, "we will proceed with the remaining approval procedures without delay through consultations with regulatory authorities." Currently, Celltrion has completed marketing authorization applications for four biosimilars?Prolia and Xgeva (CT-P41), Eylea (CT-P42), Stelara (CT-P43), and Actemra (CT-P47)?in the US, Europe, and Korea. The biosimilar for Xolair, CT-P39, has completed approval applications in Europe and Korea and will soon apply for approval in the US as well.

This content was produced with the assistance of AI translation services.