European Commission Approves Fresenius' Denosumab Biosimilars

On July 23, 2025, Fresenius made a significant announcement regarding their latest development in the pharmaceutical sector. The European Commission has granted approval for Fresenius Kabi's denosumab biosimilars, Conexxence® and Bomyntra®, to be used across Europe. These approvals apply to a wide range of medical conditions traditionally treated with the original denosumab products.

The approved applications of these biosimilars are extensive and encompass treatment for osteoporosis in both postmenopausal women and men who are considered at risk. They are also authorized for managing bone loss related to certain medical treatments and for preventing skeletal complications that may arise when cancer metastasizes to the bone. Additionally, Fresenius's biosimilars can be used in the treatment of giant cell tumors of bone, reinforcing their versatility and broad therapeutic potential.

This development is a major milestone for Fresenius Kabi as it aligns with their overarching mission to provide greater access to high-quality biosimilar therapies across the globe. The introduction of these biosimilars is expected to enhance treatment options for patients suffering from these serious health conditions and is a crucial step in expanding the reach of affordable healthcare solutions.

The approval not only marks a key achievement for Fresenius but also underscores their commitment to their strategic initiative known as the #FutureFresenius strategy. This strategy aims to bolster their Biopharma platform, which is a central component of their long-term growth and innovation plans. By securing approval for Conexxence® and Bomyntra®, Fresenius is strengthening their position within the competitive biosimilar market in Europe.

Biosimilars play a crucial role in modern healthcare, offering cost-effective alternatives to existing biologic treatments while maintaining similar efficacy and safety profiles. As patents for original biologic medicines expire, biosimilars provide an opportunity to alleviate healthcare costs, making treatments more accessible to a broader patient population. The introduction of Conexxence® and Bomyntra® is expected to contribute significantly to these efforts by providing reliable and affordable alternatives to their reference biologics.

Fresenius Kabi, known for its expertise and innovation in the biopharmaceutical field, has registered Conexxence and Bomyntra as trademarks in selected countries, further solidifying their presence and brand recognition in these regions. The successful approval by the European Commission is a testament to the rigorous standards and commitment to quality that Fresenius Kabi upholds in the development and production of its biosimilar products.

Overall, the approval of Conexxence® and Bomyntra® represents a strategic victory for Fresenius, positioning the company as a leader in the biosimilars market and reinforcing their dedication to enhancing global healthcare access. With this development, Fresenius Kabi is well-placed to make significant strides in the biopharmaceutical industry, contributing to the availability of effective and affordable treatments for a range of conditions that have a substantial impact on patients’ lives.