#Spain #Madrid #Fresenius Kabi #Denosumab #mAbxience

mAbxience Celebrates Key Milestone in Biosimilar Development

On July 2, 2025, mAbxience, a subsidiary majority-owned by Fresenius Kabi and partially owned by Insud Pharma, proudly announced that the European Commission has granted approval for its Denosumab biosimilars, Denbrayce® and Izamby®. This approval follows a favorable recommendation from the Committee for Medicinal Products for Human Use (CHMP), representing a significant advancement in mAbxience’s mission to deliver high-quality, accessible, and affordable therapies worldwide.

Denbrayce®, a biosimilar of Amgen's Xgeva®, is indicated for preventing skeletal-related events in adults with advanced malignancies affecting bone, as well as for treating adults and skeletally mature adolescents with giant cell tumors of the bone. On the other hand, Izamby®, which references Prolia®, is approved for treating osteoporosis in postmenopausal women and men at increased risk of fractures, a condition that weakens bones, making them more prone to breaks.

Jurgen Van Broeck, CEO of mAbxience, emphasized the importance of this approval, stating, "This authorization underscores mAbxience’s commitment to scientific excellence and our dedication to expanding access to vital biological therapies. We take pride in contributing to alleviating the burden of osteoporosis, cancer-related bone disorders, and rare bone diseases across Europe. This milestone brings us closer to ensuring that more patients throughout Europe can benefit from high-quality, affordable treatment options."

Denosumab, a fully human monoclonal antibody, works by inhibiting the receptor activator of nuclear factor-kappa B ligand (RANKL), ultimately preventing the development of osteoclasts, the cells responsible for bone resorption. It has proven effective in managing osteoporosis, therapy-induced bone loss, bone metastases, and giant-cell tumors of the bone.

With the approval of these biosimilars, mAbxience showcases its expertise in developing and manufacturing biosimilars, further enhancing patient access to life-changing therapies while supporting the sustainability of healthcare systems in Europe. This authorization marks a pivotal achievement in mAbxience’s objective of offering affordable, accessible, and transformative therapies globally.

The company continues to bolster its efforts with a robust pipeline and an expanding network of partners, dedicated to improving patient access to advanced treatments while assisting healthcare systems in addressing the rising costs of biologic medicines.

About mAbxience

Founded in Spain, mAbxience specializes in the development, production, and marketing of biopharmaceuticals. In August 2022, a joint agreement between Fresenius Kabi and Insud Pharma enabled Fresenius Kabi to acquire a majority stake in mAbxience, transforming it into a globally integrated biotechnology firm. With over a decade of experience, mAbxience is committed to providing accessible and affordable medicines worldwide, aiming to enhance the quality of life by ensuring broad access to high-quality drugs.

Currently, mAbxience has two approved products and a solid development pipeline, boasting a B2B presence across over 100 markets. The company has also formed partnerships with more than 30 entities and employs over 1,000 professionals. Its three multi-product facilities located in Europe and South America hold GMP certifications from prestigious regulatory authorities such as the FDA and EMA.

As a global expert in biopharmaceuticals, mAbxience also offers Contract Development and Manufacturing Organization (CDMO) services, leveraging advanced technologies and innovative platforms to provide integrated production solutions. For further information about mAbxience, its biosimilars, and CDMO operations, visit their website at www.mabxience.com or check them out on LinkedIn.