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New Approval Alert: First Denosumab Biosimilar Approved in Canada, as Sandoz Celebrates the Approval of Jubbonti®

Feb 20, 2024

On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications.  Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.   

In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.  

In March 2023, Mabwell (Shanghai) Bioscience announced that it received Chinese marketing approval for its Mailishu® (denosumab) and it was reported in December 2023 that Celltrion applied to the FDA for marketing authorisation for its Prolia® biosimilar (CT-P41).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech.