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Approval Alert: Sandoz Announces EMA Approval of First EU Denosumab Biosimilars Ahead of Nov 2025 Launch

May 22, 2024

On 22 May 2024, the European Commission approved the first denosumab biosimilars in Sandoz’s Wyost® and Jubbonti®.  The biosimilars were approved with a full indication set mirroring the approved indications of Amgen’s Xgeva® and Prolia® respectively, and have the same dosage form, route of administration, dosing regimen and presentation as the reference medicines.

Sandoz expects to launch the biosimilars in Europe “from November 2025”.

On 5 March 2024, Sandoz’s Wyost® and Jubbonti® became the first denosumab biosimilars approved in the US with interchangeability to the reference products.  As a result of settlement of pending BPCIA proceedings in the US in April 2024, Sandoz can launch its biosimilars in the US from 31 May 2025 (or earlier in certain circumstances).

Jubbonti® was approved in Canada on 20 February 2024.

Other denosumab biosimilars have been approved in China including Prolia® biosimilars Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), and Mabwell’s Xgeva® biosimilar MaiweijianTM (denosumab 120mg) (April 2024). Companies that have denosumab biosimilars under development include Samsung Bioepis, Celltrion, Alvotech, Intas, and Shanghai Henlius Biotech.