mAbxience Achieves Milestone with European Approval for Denosumab Biosimilars
mAbxience, a biotechnology firm with a majority stake held by Fresenius Kabi and additional investment from Insud Pharma, has made a significant advancement in the pharmaceutical sector. The company announced on July 2, 2025, that the European Commission has granted approval for its denosumab biosimilars, namely Denbrayce® and Izamby®. This pivotal milestone nods to mAbxience's commitment to delivering high-quality and affordable healthcare solutions globally.
The European Commission’s approval comes following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), underscoring the efficacy and safety profiles of the newly approved biosimilars, which mirror their reference biologics. The introduction of Denbrayce® is particularly noteworthy as it is indicated for preventing skeletal-related events in adults with advanced malignancies affecting the bone while also treating adult patients and skeletally mature adolescents with giant cell tumors of the bone. On the other hand, Izamby® is designed for managing osteoporosis in postmenopausal women and men at higher risk of fractures, a significant advancement in the treatment of this degenerative condition.
Jurgen Van Broeck, the CEO of mAbxience, expressed his pride regarding this achievement, highlighting, "This approval is a testament to mAbxience's dedication to scientific excellence and our commitment to broadening access to essential biologic therapies." The approval serves as a critical step in reducing the impact of osteoporosis and cancer-related bone conditions across Europe, facilitating greater accessibility to such vital treatments for patients.
Denosumab functions by inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL), effectively stunting the development of osteoclasts, which are the cells responsible for bone degradation. With its established application in treating osteoporosis, treatment-induced bone loss, and other bone-related conditions, denosumab has been pivotal in therapeutic settings. This enhancement in treatment availability marks mAbxience's ongoing efforts to render essential medications both accessible and affordable across various healthcare systems.
Further, mAbxience stands out in the industry with its robust expertise in the development and production of biosimilars. They endeavor to support healthcare frameworks as they face increasing challenges regarding the costs associated with biologic medicines. Leveraging a comprehensive pipeline of existing projects and a growing network of partners, the company is devoted to increasing patient access to cutting-edge medical therapies.
About mAbxience: mAbxience is headquartered in Spain and specializes in the development, manufacturing, and commercialization of biopharmaceutical products, contributing to global health initiatives. Following an agreement in August 2022 that led Fresenius Kabi to acquire a controlling stake in the company, mAbxience has transitioned into a global biopharmaceutical powerhouse. With over a decade of experience, mAbxience aims to enhance life quality by ensuring worldwide access to essential medicines, developing products approved in over 100 markets, and aligning with over 30 partners worldwide. Equipped with state-of-the-art multi-product facilities across Europe and South America, mAbxience operates in compliance with regulations from eminent authorities such as the FDA and EMA. Their commitment to delivering integrated manufacturing solutions through advanced technology solidifies their presence as a key player in the biopharmaceutical landscape. For more information about mAbxience’s initiatives and products, visit their official website at www.mabxience.com or find them on LinkedIn to explore their latest updates and contributions.
The European Commission’s approval comes following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), underscoring the efficacy and safety profiles of the newly approved biosimilars, which mirror their reference biologics. The introduction of Denbrayce® is particularly noteworthy as it is indicated for preventing skeletal-related events in adults with advanced malignancies affecting the bone while also treating adult patients and skeletally mature adolescents with giant cell tumors of the bone. On the other hand, Izamby® is designed for managing osteoporosis in postmenopausal women and men at higher risk of fractures, a significant advancement in the treatment of this degenerative condition.
Jurgen Van Broeck, the CEO of mAbxience, expressed his pride regarding this achievement, highlighting, "This approval is a testament to mAbxience's dedication to scientific excellence and our commitment to broadening access to essential biologic therapies." The approval serves as a critical step in reducing the impact of osteoporosis and cancer-related bone conditions across Europe, facilitating greater accessibility to such vital treatments for patients.
Denosumab functions by inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL), effectively stunting the development of osteoclasts, which are the cells responsible for bone degradation. With its established application in treating osteoporosis, treatment-induced bone loss, and other bone-related conditions, denosumab has been pivotal in therapeutic settings. This enhancement in treatment availability marks mAbxience's ongoing efforts to render essential medications both accessible and affordable across various healthcare systems.
Further, mAbxience stands out in the industry with its robust expertise in the development and production of biosimilars. They endeavor to support healthcare frameworks as they face increasing challenges regarding the costs associated with biologic medicines. Leveraging a comprehensive pipeline of existing projects and a growing network of partners, the company is devoted to increasing patient access to cutting-edge medical therapies.
About mAbxience: mAbxience is headquartered in Spain and specializes in the development, manufacturing, and commercialization of biopharmaceutical products, contributing to global health initiatives. Following an agreement in August 2022 that led Fresenius Kabi to acquire a controlling stake in the company, mAbxience has transitioned into a global biopharmaceutical powerhouse. With over a decade of experience, mAbxience aims to enhance life quality by ensuring worldwide access to essential medicines, developing products approved in over 100 markets, and aligning with over 30 partners worldwide. Equipped with state-of-the-art multi-product facilities across Europe and South America, mAbxience operates in compliance with regulations from eminent authorities such as the FDA and EMA. Their commitment to delivering integrated manufacturing solutions through advanced technology solidifies their presence as a key player in the biopharmaceutical landscape. For more information about mAbxience’s initiatives and products, visit their official website at www.mabxience.com or find them on LinkedIn to explore their latest updates and contributions.
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