Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Paul Johns
Trade Marks

Sandoz and Amgen Resolve US Denosumab Biosimilar Dispute; Launch from 31 May 2025

Apr 29, 2024

On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.

This concludes the District Court proceedings Amgen commenced against Sandoz in New Jersey on 1 May 2023 alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva®.  The proceedings followed the FDA’s acceptance of Sandoz’s BLA for Jubbonti® and Wyost® in February 2023.

Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively.  No other denosumab biosimilars have received US approval to date.

In March 2024, the CHMP of the European Medicines Agency adopted a positive opinion for Sandoz’s denosumab biosimilars.  Jubbonti® was approved in Canada on 20 February 2024.  Other denosumab biosimilars have been approved in China: Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), both biosimilars to Prolia®, and Mabwell’s MaiweijianTM (denosumab 120mg) (April 2024), biosimilar to Xgeva®. Companies that have denosumab biosimilars under development include Samsung BioepisCelltrion, Alvotech, Intas, and Shanghai Henlius Biotech.