Sandoz AG (SDZNY, SDZXF) and Amgen Inc. (AMGN) have reached an agreement to resolve all patent litigation related to Sandoz’s U.S. denosumab biosimilars. The agreement clears the way for the launch of denosumab biosimilars Jubbonti and Wyost on May 31, 2025, or earlier under certain circumstances.
“The terms of the agreement will not impact our previously disclosed 2024 guidance,” Sandoz said in a statement.
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024. Jubbonti and Wyost are interchangeable with and approved by the FDA for all indications of reference medicines Prolia and Xgeva. They have the same dosage form, route of administration, dosing regimen, and presentation as the respective reference medicines.
Denosumab is a human monoclonal antibody used for osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.
Patent infringement proceedings were initially filed by Amgen in the U.S. Federal District Court for the District of New Jersey in May 2023, the statement said. The litigation was resolved, followed by Sandoz’s defense against Amgen’s claims that the company infringed on up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva.
In January, the FDA added a serious warning to the prescribing information for Amgen’s drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific patient groups. The boxed warning was implemented following a 2022 review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly those undergoing dialysis while using Prolia.
Price Action: AMGN shares are trading lower by 0.91% at $273.86 at the last check Tuesday.
