Sandoz has received approval from the US Food and Drug Administration (FDA) for the first biosimilars of Amgen’s bone disease therapy, denosumab.
Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) have been authorised as interchangeable biosimilars for all indications covered by Amgen’s reference medicines Xgeva (denosumab) and Prolia (denosumab), respectively.
A biosimilar, according to the US regulator, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may benefit from potentially lower healthcare costs.
Wyost has been approved to treat bone complications from cancer, including bone metastases associated with solid tumours and multiple myeloma, while Jubbonti has been approved for the treatment of osteoporosis in certain patient populations.
Both biosimilars have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
Sandoz’s US application was supported by clinical studies and evidence demonstrating no clinically meaningful differences from reference medicines.
Keren Haruvi, president of Sandoz North America, said: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.”
Bone is the third most frequent site for metastatic tumours, with nearly all types of cancer able to spread to the bone and cause pain and fractures.
More than ten million US adults aged over 50 years are estimated to have osteoporosis, a condition that weakens bones, making them fragile and more likely to break. The disease disproportionately impacts postmenopausal women, and half of all women aged over 50 years will experience an osteoporotic fracture during their lifetime.
Sandoz has a range of marketed biosimilars, including Tyruko (natalizumab-sztn), which was approved by the FDA in August to treat adults with relapsing forms of multiple sclerosis (MS).
The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is the first biosimilar to be approved by the US regulator for this patient population.