#Spain #Madrid #Healthcare Access #Denosumab Biosimilars #mAbxience

Introduction

The landscape of biopharmaceutical therapies is continuously evolving, and one of the most exciting recent developments comes from mAbxience, a noteworthy player in this arena. Based in Spain and partially owned by Insud Pharma, mAbxience is on a mission to strengthen access to vital health solutions across the globe. Recently, on July 2, 2025, the company announced the approval of its denosumab biosimilars—Denbrayce® and Izamby®—by the European Commission, marking a significant leap for both mAbxience and patients in need.

The Approval Process

The approval of Denbrayce® and Izamby® follows favorable recommendations by the Committee for Medicinal Products for Human Use (CHMP). This endorsement highlights the safety, efficacy, and overall quality of these biosimilars, positioning mAbxience as a trusted innovator within the biopharmaceutical sector. The company's CEO, Jurgen Van Broeck, enthusiastically expressed pride in this achievement, underscoring mAbxience's commitment to providing affordable therapies for conditions like osteoporosis and various malignancies associated with bone health.

Products Overview

Denbrayce® serves as a biosimilar to Amgen's Xgeva®, specifically engineered for the prevention of skeletal-related events in adults with advanced malignancies. This condition often leads to severe pain and complications, significantly impacting patients' quality of life. On the other hand, Izamby® is comparable to Amgen's Prolia®, providing a treatment avenue for osteoporosis, particularly for postmenopausal women and men at heightened risk of fractures.

Both products exhibit the potential not only to improve patient outcomes but also to alleviate the broader healthcare burden associated with these critical health issues.

Mechanism of Action

At the heart of both Denbrayce® and Izamby® is denosumab, a human monoclonal antibody that inhibits receptor activator of nuclear factor kappa-B ligand (RANKL). By doing so, it prevents the formation and activity of osteoclasts, the cells responsible for bone breakdown. This mechanism is fundamental for the management of conditions such as osteoporosis and other malignant bone diseases, reinforcing the need for accessible treatments.

The Importance of Affordable Treatments

The approval of these biosimilars highlights an essential shift towards improving access to high-caliber biopharmaceutical therapies. By lowering production costs and enhancing market entry for biosimilars, mAbxience aims not only to support public health goals but also to ensure the sustainability of healthcare systems grappling with rising treatment costs. The company’s rigorous standards in quality assurance guarantee that these medications deliver the same therapeutic effect as their branded counterparts, further solidifying patient trust in biosimilars.

Looking Ahead: mAbxience’s Future in Biopharmaceuticals

As mAbxience moves forward, it demonstrates a commitment to maintaining a robust pipeline of potential therapeutics while forming strategic partnerships that expand its market reach. With over a decade of experience in biotechnology and a presence in more than 100 markets alongside a team of over 1,000 dedicated professionals, the company is well-positioned for future advancements.

The company’s multi-product manufacturing facilities in Europe and South America have received Good Manufacturing Practices (GMP) approval from several stringent regulatory bodies, reinforcing its role as a major player in the global biopharmaceutical landscape.

Conclusion

In summary, mAbxience's achievement in obtaining European Commission approval for Denbrayce® and Izamby® marks an important milestone not just for the company, but for patients seeking affordable and effective treatment options. By successfully launching these biosimilars, mAbxience is paving the way for broader access to essential therapies and contributing positively to public health outcomes across Europe. As the company continues its journey, the healthcare community looks forward to the further innovations and products that mAbxience will undoubtedly bring to market in the coming years.