FDA clears Sandoz’s denosumab biosimilars, but Amgen’s lawsuit means no launch date

05 Mar 2024
firstwordpharma.com
Drug ApprovalPatent InfringementPatent Expiration
The FDA on Tuesday approved denosumab-bbdz from Sandoz as Wyost to prevent skeletal-related events in certain cancer patients, and as Jubbonti for some patients with osteoporosis. The biosimilars scored interchangeable status with Xgeva and Prolia, respectively, from Amgen.
SandozSandoz, which was spun off from Novartis last year, said it would not comment on a launch for either product due to ongoing patent litigation. Amgen filed suit last year to prevent Sandoz's biosimilars from entering the market until expiration of key US denosumab patents, which could come as early as next year.
Wyost and Jubbonti are approved for the same indications and with the same dosing regimens as their respective reference medicines. Last year, Xgeva brought in $2.1 billion in sales, while Prolia raked in $4 billion.
Like Xgeva, Wyost is cleared to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours; to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable; and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
Jubbonti has the same label as Prolia – which means it also carries the boxed warning FDA recently bestowed upon the latter for an increased risk of severe hypocalcaemia in patients with advanced chronic kidney disease (CKD), particularly those on dialysis.
The biosimilar is approved for individuals at high risk for fracture, including postmenopausal women with osteoporosis, men with osteoporosis, men and women with glucocorticoid-induced osteoporosis, men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer.
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