Sandoz Nabs FDA Approvals for First Two Biosimilars for Amgen’s Denosumab

06 Mar 2024
Drug ApprovalBreakthrough Therapy
Pictured: FDA's signage at its headquarters/iStock, JHVEPhoto The FDA on Tuesday approved two of Sandoz’s biosimilars for Amgen’s blockbuster bone-preserving therapy denosumab, though the Novartis spin-off is keeping mum on its target launch date, pricing and other launch details. Sandoz’s Jubbonti will challenge Amgen’s Prolia for the treatment of osteoporotic men and postmenopausal women who are at high risk of fracture. Like its branded reference product, the biosimilar is also indicated for glucocorticoid-induced osteoporosis. Jubbonti can also be used to boost bone mass in men undergoing androgen deprivation therapy for nonmetastatic cancer, as well as women at high risk of fractures and who are being treated with adjuvant aromatase inhibitors for breast cancer. Amgen’s Xgeva will face off against Sandoz’s Wyost, which can now be used to prevent skeletal-related events in patients with multiple myeloma and solid tumors with bone metastases. The biosimilar is also approved to treat unresectable giant cell tumor of the bone and hypercalcemia of malignancy refractory to bisphosphonate therapy. Jubbonti and Wyost have the same dosage form, route of administration, dosing regimen and presentation as their respective reference products. The two biosimilars have also won the FDA’s interchangeability designation, allowing them to be substituted for Prolia and Xgeva without needing to change the patient’s prescription. Sandoz North America President Keren Haruvi in a statement said that Jubbonti and Wyost represent “the first FDA approval for biosimilars to denosumab” which can help improve access to life-changing treatment for patients suffering from osteoporosis and cancer-related bone events. However, due to “ongoing patent litigation” surrounding the biosimilars, Sandoz has not disclosed its expected launch timelines for Jubbonti and Wyost including other details such as pricing. Denosumab is a fully human monoclonal antibody that targets and binds the RANKL cytokine, which is a central player in bone turnover. By blocking the RANKL signaling cascade, denosumab can inhibit bone the resorption process and increase bone strength and mass. Denosumab was first approved in June 2010 as Prolia for use in postmenopausal women with osteoporosis. The antibody won its second approval as Xgeva a few months later in November 2010 to prevent skeletal events in solid tumor patients with bone metastases. Both therapies have since become strong commercial assets for Amgen. In 2023, Prolia brought in over $4 billion in revenue, representing a 12% increase from its 2022 sales of nearly $3.63 billion. Xgeva also demonstrated strong 5% year-over-year sales growth, reaching $2.1 billion in 2023 from a little more than $2 billion in 2022. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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