Budapest / London, September 29, 2025 Gedeon Richter and Hikma announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Applications for their biosimilar versions of denosumab, named Enoby and Xtrenbo, referencing the original brands Prolia and Xgeva.
Science Significance
The approvals are based on a robust package of analytical, nonclinical, and clinical evidence demonstrating that the biosimilars are highly similar to reference denosumab in quality, safety, efficacy, and immunogenicity. Denosumab works by inhibiting RANKL, preventing osteoclast formation and function, and thereby reducing bone resorption. This scientific validation reinforces the reliability of biosimilars as effective therapeutic options.
Regulatory Significance
This decision represents Gedeon Richter’s first FDA-approved biosimilars, reflecting successful completion of the rigorous U.S. regulatory pathway for biologics. By demonstrating comparability to the original products, the company has set an important precedent for further biosimilar approvals, supporting the FDA’s mission to increase treatment access while maintaining patient safety.
Business Significance
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For Gedeon Richter, this regulatory success marks a strategic entry into the U.S. biosimilar market, one of the largest and most competitive healthcare markets globally. The approval strengthens the company’s position in biologics, with commercial potential across therapeutic areas involving osteoporosis and oncology-related bone complications. It also reinforces the importance of biosimilars in driving competition and lowering healthcare costs.
Patients’ Significance
For patients, the FDA approval translates into greater access to affordable treatment options. Those managing osteoporosis, bone metastases, or giant cell tumor of bone can now benefit from biosimilars that provide the same therapeutic value at potentially reduced costs. Increased availability of effective biologic therapies is expected to improve both affordability and treatment adherence.
Policy Significance
The decision highlights the importance of biosimilar-friendly regulatory and healthcare policies that encourage competition, reduce spending, and increase accessibility. As healthcare systems grapple with the rising cost of biologics, the approval demonstrates how regulatory agencies can support sustainable patient care through timely review and endorsement of biosimilars.
With the FDA’s approval of biosimilar denosumab, Gedeon Richter advances both scientific innovation and patient access, delivering meaningful impact for healthcare systems and communities. This milestone strengthens confidence in biosimilars as safe and effective alternatives, ensuring that critical biologic therapies reach more patients at lower cost while sustaining innovation in the pharmaceutical industry.
Source: Gedeon Richter Press Release
