4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing with the US FDA for its biosimilar CT-P41 of the osteoporosis medication Prolia-Xgeva (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 US, including the prevention of skeletal complications due to osteoporosis, Bone loss, multiple myeloma, and bone metastasis from solid tumours, as well as giant cell tumours of bone.

Read Business Korea article