Sandoz gains approval for first and only biosimilars of denosumab in Europe

22 May 2024

Swiss generic and biosimilar medicines company Sandoz (SWX: SDZ) today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe.

Developed by US biotech major Amgen (Nasdaq: AMGN) and initially approved in 2010, denosumab is a big seller for the company, both as Prolia for the treatment of osteoporosis and Xgeva for bone cancer. Prolia alone generated sales of $4 billion in 2023.

These are key biosimilar value drivers for the company over the mid-term and their approval is a major step in advancing the Sandoz growth strategy, the company noted. Sandoz said it expects to launch from November 2025 onwards.

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