#Spain #Madrid #mAbxience #Denbrayce #Izamby

mAbxience's Breakthrough Approval: Denosumab Biosimilars

mAbxience, a prominent biotechnology company with a focus on providing high-quality, affordable therapies, recently celebrated a crucial milestone with the approval of its denosumab biosimilars, Denbrayce® and Izamby®, by the European Commission. This significant achievement follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and reinforces the company's commitment to enhancing patient access to critical treatments across Europe.

The Significance of Denosumab Biosimilars

Denbrayce® and Izamby® are biosimilars that replicate the effects of Amgen's drugs Xgeva® and Prolia®, respectively. These biosimilars provide essential treatment options for patients dealing with severe health conditions. Denbrayce® is designed for adults facing advanced malignant tumors affecting bone structures, aiming to prevent skeletal-related diseases. On the other hand, Izamby® targets postmenopausal osteoporosis in women and men, helping mitigate their risk of fractures.

Jurgen Van Broeck, CEO of mAbxience, emphasized the company’s dedication to scientific excellence and the mission of broadening access to necessary biological therapies. This approval reflects mAbxience’s effort to alleviate the burden of osteoporosis and related bone diseases in Europe while ensuring that quality treatments remain affordable for patients.

Denosumab: A Game Changer in Treatment

Denosumab is a human monoclonal antibody that inhibits RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), which is critical in the formation and activity of osteoclasts responsible for bone degradation. Its established track record in treating osteoporosis, bone loss due to therapy, and bone tumors makes denosumab an indispensable part of modern medical treatment paradigms.

With the introduction of these biosimilars, mAbxience solidifies its expertise in the development and manufacturing of impactful biosimilars. This advancement not only enhances patient access to life-changing therapies but also supports the sustainability of healthcare systems facing increasing biological drug costs.

A Vision for Accessible Healthcare

mAbxience's journey began with a clear vision: to develop affordable and accessible biopharmaceuticals aimed at improving patients’ quality of life worldwide. After becoming a subsidiary of Fresenius Kabi, the company bolstered its capabilities and expanded its portfolio of products in development. Currently, mAbxience operates in over 100 markets, demonstrating its strong presence in the industry.

As part of its strategy, mAbxience collaborates with 30 partners and employs a dedicated team of over 1,000 professionals. Their manufacturing capabilities are underscored by facilities in Europe and South America, all of which have received Good Manufacturing Practice (GMP) certifications from leading regulatory bodies such as the FDA and EMA.

Commitment to Future Growth

The approval of Denbrayce® and Izamby® not only signifies a triumph for mAbxience but sets the stage for future endeavors. The company aims to enhance its product portfolio and continue to innovate in the realm of biosimilars, thus augmenting patient access to advanced therapies. mAbxience is committed to addressing healthcare challenges by providing more patients with effective treatment options that are both affordable and impactful.

For more details on mAbxience’s latest biosimilars or to learn about their ongoing projects and initiatives, visit www.mabxience.com or connect with them on LinkedIn.