Sandoz Gains European Approval for First Denosumab Biosimilars Wyost® and Jubbonti®

Sandoz, a prominent player in the field of generic and biosimilar medicines, has announced that the European Commission (EC) has approved two biosimilar drugs, Wyost® (denosumab) and Jubbonti® (denosumab). These biosimilars are set to be the first of their kind in Europe, providing alternatives to the reference medicines Xgeva® and Prolia®. This approval marks a significant achievement for Sandoz, aligning with their strategic growth plans. The company plans to introduce these medications starting from November 2025.

Wyost® is designed for the treatment of cancer-related bone diseases, while Jubbonti® is focused on treating osteoporosis. The approvals were supported by comprehensive development programs that demonstrated these biosimilars match the reference medicines in safety, efficacy, and quality.

Claire D'Abreu-Hayling, the Chief Scientific Officer at Sandoz, emphasized the significance of these approvals, stating that bone loss due to primary and secondary causes, as well as cancer-related bone complications, impose a heavy burden on patients and society. She highlighted the importance of improving access to these transformative medicines and reiterated Sandoz's ongoing commitment to providing sustainable treatment options.

Cancer remains a significant health challenge in Europe, with nearly one-quarter of the world's new cancer cases reported in the region. Cancer is a leading cause of premature death among individuals aged 30-69 in many European countries. Bone metastases, which can lead to pain and fractures, are common in various types of cancer, notably breast and prostate cancer.

Osteoporosis also poses a substantial health issue in Europe. In 2019, an estimated 32 million people over the age of 50 were living with osteoporosis. The number of fractures related to osteoporosis is projected to increase by about 25% by 2034. Despite the availability of treatments, many patients at high risk do not receive adequate care, even after experiencing fractures.

Wyost® and Jubbonti® have been carefully developed to mirror their reference medicines. Both drugs contain denosumab, a human monoclonal antibody that specifically targets and binds to RANKL, a key protein involved in bone resorption. By inhibiting the interaction between RANKL and its receptor RANK on osteoclast precursors and osteoclasts, these medications help prevent bone resorption and maintain bone density.

Wyost® is authorized in Europe to prevent skeletal-related events such as pathological fractures, radiation to bone, spinal cord compression, or surgery to bone in adults with advanced cancers involving bones. It is also approved for treating adults and skeletally mature adolescents with unresectable giant cell tumors of bone or when surgical resection is likely to cause severe morbidity.

Jubbonti® is approved in Europe to treat osteoporosis in postmenopausal women and men at increased risk of fractures. It is also indicated for treating bone loss associated with hormone ablation in men with prostate cancer and with long-term systemic glucocorticoid therapy in adults at increased risk of fractures.

These approvals underscore Sandoz's dedication to pioneering access to essential medications and addressing critical healthcare needs in Europe and beyond.