The FDA recently approved one… no wait, two… no wait, is it really one times two denosumab biosimilars…..?? The/these approval/s include Ospomyv (denosumab-dssb) and Xbryk (denosumab-dssb)… it/they are from Samsung Bioepis.
NO WAIT… the FDA approved yet another pair of denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) from Celltrion.
And if that’s not enough, Wyost and Jubbonti were approved as Prolia and Xgeva biosims in 2024.
All of these biosims were approved as interchangeable with the reference products, Prolia and Xgeva from Amgen.
You should be familiar with the big differences between these ‘twin’ injectables. But, one has a twice yearly administration schedule… the other has a much more frequent dosing schedule. While both products are included in the same FDA approved prescribing information document you need to scroll way down (e.g., page 96) to read the details for the ‘twin’s’ therapy detail and the dosing information for completely different indications.
CLICK HERE to access prescribing information for Ospomyv and Xbryk
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