Amgen and Sandoz settle dispute over blockbuster bone condition drugs
Agreement clears the way for Sandoz to launch denosumab biosimilars in May 2025 | Dispute over multiple patents covering Prolia and Xgeva resolved.
Amgen has settled its patent infringement litigation with Sandoz, it was announced yesterday (April 29), with a deal that allows the Swiss generics manufacturer to launch its biosimilar versions of Amgen’s blockbuster drugs Prolia and Xgeva next year.
The court ordered that the claims of Amgen’s US patent number 7,364,736 were valid and had been infringed by Sandoz’s denosumab biosimilars in the US, Amgen said on Monday.
A confidential settlement resolved the remaining patent disputes in the lawsuit, and cleared the way for Sandoz to launch its denosumab biosimilar products on May 31, 2025 or earlier under certain conditions.
Provided BLA ‘prematurely’
The California-headquartered biotech firm sued Sandoz at the US District Court for the District of New Jersey on May 1, 2023, alleging infringement of 21 patents through its proposed biosimilars to Amgen’s bone treatment drugs.
Denosumab—sold under the Prolia and Xgeva brand names—is used to treat various bone conditions, including osteoporosis and multiple myeloma or bone metastases from certain types of cancer.
Sandoz submitted a biologics licence application (BLA) to the US Food and Drug Administration (FDA) in late 2022, which was accepted in February 2023.
Amgen claimed that Sandoz had provided it with a copy of its BLA “prematurely” before it had been approved and then failed to provide other relevant information so it could determine whether certain patents would be infringed.
Commenting on yesterday’s agreement, Amgen said in a statement: “This settlement and court decision affirm the strength of Amgen’s patent rights for denosumab.
“Amgen remains confident in the proven benefits of Prolia (denosumab) for millions of patients worldwide with osteoporosis and other bone loss conditions and Xgeva (denosumab) for patients with multiple myeloma or bone metastases from certain types of cancer.
“We are committed to continuing to provide and maintain access for these important medicines, while vigorously defending our patent rights.”
First denosumab biosimilars approved
In a statement released today (April 30), Sandoz said that it had received FDA approval for the first and only denosumab biosimilars, Jobbonti and Wyost, on March 5 this year.
The medicines were interchangeable with and approved by the FDA for all indications of Prolia and Xgeva, the company went on.
“The settlement clears the path to bring both Jubbonti and Wyost to the US market on May 31, 2025, or earlier under certain circumstances,” Sandoz said.
“Bringing denosumab to market allows us to further our purpose of pioneering access for patients, by providing them with affordable high-quality medicines.
“The terms of the agreement will not impact our previously disclosed 2024 guidance.”
Sandoz was formerly a division of Novartis, with the companies parting ways in October 2023.
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