mAbxience and Biosidus sign an agreement to manufacture Agalsidase Beta

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mAbxience announced in February 2024 a pivotal agreement with Biosidus to manufacture Agalsidase Beta. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease.

Fabry Agalsidase beta V17J06

mAbxience, a company specialized in the development and manufacturing of biopharmaceutical products and a part of the Fresenius Kabi and Insud Pharma groups [1], announced on 5 February 2024, a significant agreement with Biosidus, an Argentine company specializing in biotechnology. The agreement, focused on the Contract Development and Manufacturing Organization (CDMO) area, entails mAbxience being responsible for manufacturing the active ingredient Agalsidase Beta, developed by Biosidus as a biosimilar of Fabrazyme.

Fresenius Kabi acquired a majority stake in the biosimilars company mAbxience by mid-2022 [1].

The use of Agalsidase Beta is an innovative treatment indicated for Fabry disease. This disease results from the total or partial deficiency of the lysosomal enzyme alpha-galactosidase A, leading to the pathological accumulation of glycosphingolipids in vascular walls, differentiated cells, and fluids. Recent analyses of some international neonatal research results show a frequency of 1 in 22,570 males with classical forms and 1 in 1,390 with late-onset forms, positioning it as the most common lysosomal storage disease.

The product has been developed entirely by the Research and Development team of Biosidus and is already advanced in phase III. If everything continues as planned, once it receives the necessary approvals, it will be initially marketed in Argentina, and subsequently in other countries around the world. It still does not have a commercial name.

According to reports from both companies, the agreement represents a significant achievement for both parties. On one hand, mAbxience strengthens its position in the CDMO sector. Meanwhile, for Biosidus, this agreement provides the opportunity to expand its influence in the pharmaceutical industry globally. This is because it is the first biosimilar molecule to emerge from an emerging country for Fabrazyme, developed entirely in Latin America. Existing biosimilars in Japan and Korea are also taken into account.

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1. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquire mAbxience and Ivenix []. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 9]. Available from:

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