Celltrion announced on Nov. 30 (local time) that it has completed the application for product licensing with the U.S. Food and Drug Administration (FDA) for its biosimilar CT-P41 of the osteoporosis medication Prolia-Xgeva (active ingredient: denosumab).
Based on the results of global Phase 3 clinical trials, Celltrion has applied for product licensing for CT-P41 for all indications (Full Label) held by the original products Prolia and Xgeva in the U.S., including the prevention of skeletal complications due to osteoporosis, bone loss, multiple myeloma, and bone metastasis from solid tumors, as well as giant cell tumors of bone. Following the U.S., the company plans to sequentially apply for approvals in other major global markets, including Europe.
In October, Celltrion conducted global Phase 3 clinical trials on 477 postmenopausal women with osteoporosis in four countries, including Poland and Estonia, confirming the equivalence and pharmacokinetic similarity to the original drugs.
Throughout the development process, Celltrion has been in continuous consultation with the FDA and the European Medicines Agency (EMA), designing a global development program based on the global Phase 3 clinical results to ensure that CT-P41 can be simultaneously approved as a biosimilar to both Prolia and Xgeva.
Once the approval of CT-P41 in the U.S. is completed, it is expected to secure the status of an interchangeable biosimilar, enabling substitution prescriptions for the original products, thereby rapidly penetrating the market and increasing accessibility for patients.
Prolia, an osteoperosis medication produced by multinational pharmaceutical company Amgen, has the same active ingredient as Xgeva, a drug approved for preventing bone metastasis complications in cancer patients. Last year, it recorded sales of US$5.83 billion according to IQVIA. The patents for Prolia are set to expire in February and November 2025 in the U.S. and Europe, respectively.