The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024. It is reported that the clinical trial showed CT-P41 has equivalent efficacy, pharmacokinetics and safety to Prolia® in postmenopausal women with osteoporosis.
Celltrion applied to the FDA for marketing authorisation of CT-P41 in December 2023. The first Prolia® (denosumab) biosimilar approved in the US was Sandoz’s Jubbonti®, on 5 March 2024.
Prolia® (denosumab) biosimilars have been approved in Canada (Sandoz’s Jubbonti® on 20 February 2024) and China (Boan Biotech’s Boyoubei® in November 2022 and Mabwell’s Mailishu® in March 2023). Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech.