Sandoz and Amgen Settle Denosumab Biosimilars Patent Litigation

Sandoz AG and Amgen Inc have reached an agreement to resolve all patent litigation related to Sandoz’s U.S. denosumab biosimilars, Jubbonti and Wyost. The agreement clears the way for the launch of these biosimilars on May 31, 2025, or earlier under certain circumstances.

Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars, in March 2024. These biosimilars are interchangeable with and approved for all indications of the reference medicines, Prolia and Xgeva. Patent infringement proceedings were initially filed by Amgen in May 2023, alleging that Sandoz infringed on up to 21 patents protecting Prolia and Xgeva. The litigation has now been resolved.

AbbVie Q1 Earnings Preview: Analysts Forecast Earnings Decline, Watch for Humira Impact

AbbVie is set to release its first-quarter earnings results on Friday, April 26th, before the market opens. Analysts anticipate a profit of $2.26 per share, an 8.1% decrease year-over-year, on revenue of $11.94 billion, a 2.4% decline from the same period last year. Investors will be particularly interested in the company’s comments regarding its strategy for addressing Humira’s biosimilar challenges and its post-Humira growth prospects, as well as any updates on pricing trends for the upcoming quarters.

Biosimilars Fail to Deliver Promised Savings for Patients

A study has found that two years after biosimilars became available in the U.S., a higher proportion of patients using brand-name biologics were paying out-of-pocket costs, which were also, on average, 12% higher than before. In addition, patients who used biosimilars often did not pay lower out-of-pocket costs than those who were given brand-name biologic medicines. The findings suggest that the arrival of biosimilars has failed to fully deliver on their promise of lower costs for patients.

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