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Biosimilars Receives Landmark Approval from European Commission

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Biosimilars Wyost® and Jubbonti® have received landmark approval from the European Commission (EC), marking the first biosimilar versions of denosumab to be authorized in Europe. This significant milestone indicates a major advancement in the Sandoz growth strategy, as the company asserts. Wyost® (denosumab) is approved for treating cancer-related bone disease, while Jubbonti® (denosumab) is authorized for the treatment of osteoporosis. These approvals mirror the reference medicines Xgeva® and Prolia® but are offered as biosimilar alternatives, providing potentially life-changing treatments at possibly lower costs and improved accessibility.

In March, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved a new formulation for Xgeva (denosumab) via the agency’s new International Recognition Procedure (IRP). This step was pivotal in paving the way for the EC’s subsequent approval of Sandoz’s biosimilars.

The authorization of Wyost® and Jubbonti® underscores the critical need for increased access to essential medicines. Claire D’Abreu-Hayling, Sandoz’s Chief Scientific Officer, highlighted the immense disease burden of primary and secondary bone loss and cancer-related bone events on patients, the economy, and society. She emphasized that the approval of the first European denosumab biosimilars reflects a significant recognition of this need and demonstrates Sandoz’s commitment to providing sustainable treatment options.

New Denosumab Biosimilars Targeting Bone Resorption and Expanding Treatment Options

Wyost® and Jubbonti® both contain denosumab, a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand). By inhibiting osteoclast formation, function, and survival, denosumab effectively reduces bone resorption in both cortical and trabecular bone. This mechanism of action is crucial in managing conditions associated with excessive bone degradation.

  • Wyost®: Approved for preventing skeletal-related events in adults with advanced malignancies involving bone.
  • Jubbonti®: Indicated for treating osteoporosis in postmenopausal women and men at higher risk of fractures. Also authorized for treating bone loss associated with hormone ablation in males with prostate cancer at higher fracture risk.

Sandoz anticipates launching these biosimilars in Europe by November 2025 at the earliest. The introduction of these biosimilars into the market is expected to enhance treatment accessibility and affordability, thereby benefiting a broader patient population.

Biosimilars

First Denosumab Biosimilars in Europe Approved, Marking a Milestone in Cost-Effective Treatment Options

The approval of Wyost® and Jubbonti® as the first denosumab biosimilars in Europe signifies a crucial development in the pharmaceutical landscape. Biosimilars, being highly similar to their reference biologics, offer the same therapeutic benefits but typically at reduced costs. This not only provides more options for healthcare providers and patients but also drives competitive pricing, which can lead to substantial savings for healthcare systems.

Moreover, the European Commission’s decision aligns with global efforts to promote the use of biosimilars, which can help address the growing demand for biologic therapies in treating various complex and chronic conditions. By ensuring that these biosimilars meet rigorous regulatory standards for quality, safety, and efficacy, the EC helps maintain trust and confidence in biosimilar products.

The EC’s approval of Sandoz’s Wyost® and Jubbonti® as the first biosimilar versions of denosumab in Europe marks a significant milestone in the field of medical treatments. This move is expected to provide patients with more treatment options, enhance the sustainability of healthcare systems, and foster innovation in the pharmaceutical industry. As the healthcare landscape continues to evolve, such approvals underscore the importance of biosimilars in delivering cost-effective, high-quality care to patients worldwide.

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Resoruce: Sandoz, May 22, 2024

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