Sandoz reaches agreement with Amgen on denosumab biosimilars
Sandoz shared that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the Food and Drug Administration approved Sandoz denosumab biosimilars.
Patent infringement proceedings were initially filed by Amgen in the U.S. Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act. Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva. Under the terms of the agreement, Sandoz may enter the U.S. market with a biosimilar version of Prolia and Xgeva on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered.
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 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, the company said.
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“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 said.
Wyost is approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
Jubbonti is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
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