Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have therapeutic equivalence to Prolia®, with similar safety profiles.  

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab was accepted for review by the US FDA as biosimilar to Prolia®.