EC Approves Sandoz Biosimilars for Bone Ailments

The European Commission (EC) has recently approved the marketing of Sandoz’s biosimilars, Wyost and Jubbonti, aimed at treating bone-related conditions. These biosimilars are the first to be approved in Europe that reference the medicines Xgeva and Prolia.

Wyost is designed to prevent skeletal-related incidents in adults with advanced bone-involving malignancies. It is also suitable for treating adults and skeletally mature adolescents suffering from giant cell bone tumors. On the other hand, Jubbonti is intended for managing osteoporosis in postmenopausal women and men who are at a heightened risk of fractures, along with other bone loss conditions.

Sandoz plans to roll out these biosimilars by November 2025. The company has highlighted the importance of these products in addressing the significant disease burden associated with primary and secondary bone loss and cancer-related bone issues. Sandoz’s Chief Scientific Officer, Claire D’Abreu-Hayling, emphasized that the approval of these biosimilars marks a critical step towards enhancing access to potentially transformative medications, reinforcing the company's commitment to providing sustainable treatment options.

Both Wyost and Jubbonti contain denosumab, a human monoclonal antibody that disrupts the RANKL/RANK interaction. This interaction is pivotal in preventing the formation and activity of osteoclasts, the cells responsible for bone resorption. By inhibiting these cells, the biosimilars help maintain bone integrity, offering significant therapeutic benefits.

The EC’s decision to authorize these biosimilars was founded on extensive development programs that confirmed their similarity to the reference medicines in terms of dosage form, administration route, dosing regimen, and presentation. These programs demonstrated that Wyost and Jubbonti effectively match the originals in their therapeutic properties and safety profiles.

In addition to the European approval, the US Food and Drug Administration (FDA) granted approval to Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) in March 2024. This dual approval from both the EC and FDA underscores the robustness of the clinical data supporting these biosimilars and their potential to improve patient outcomes.

The introduction of Wyost and Jubbonti is particularly significant in the context of the growing need for effective treatments for bone-related conditions. Osteoporosis and other bone-related ailments pose substantial challenges not only for individual patients but also for healthcare systems and economies. By providing more affordable alternatives to existing treatments, these biosimilars could play a crucial role in enhancing patient access to necessary medications and reducing the overall disease burden.

In conclusion, the EC’s marketing authorization for Sandoz’s Wyost and Jubbonti represents a major milestone in the treatment of bone-related conditions. With their planned launch in November 2025, these biosimilars are poised to offer new hope to patients dealing with serious bone disorders. Sandoz’s commitment to delivering high-quality, sustainable treatment options continues to drive advancements in the biosimilars market, promising better health outcomes for patients across Europe and beyond.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!