News | February 5, 2024

mAbxience And Biosidus Sign CDMO Agreement For The Manufacture Of Agalsidase Beta For The Treatment Of Fabry Disease

  • This agreement strengthens mAbxience’s position in the CDMO area, highlighting its ability to collaborate in the manufacture of complex, high-value biopharmaceuticals.
  • Agalsidase Beta has been fully developed by Biosidus’ R&D team and is already advanced in the clinical phase. Once it has the corresponding approvals, it will be initially commercialized in Argentina, with plans to expand to other international markets.
  • This agreement reinforces the commitment of both companies to innovation and patient access to high quality treatments at affordable prices.

mAbxience, a leading company in the development and manufacture of biopharmaceutical products, and part of the Fresenius Kabi and Insud Pharma groups, has announced today an important agreement with Biosidus, a renowned Argentine company specialized in biotechnology. This agreement, focused in the area of CDMO (Contract Development and Manufacturing Organization), implies that mAbxience will be responsible for the manufacture of the active ingredient Agalsidase Beta, developed by Biosidus as a biosimilar of Fabrazyme.

The use of Agalsidase Beta is an innovative treatment for Fabry disease. This disease results from the total or partial deficiency of the lysosomal enzyme a-galactosidase A, which results in 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 classic forms and 1 in 1,390 in late forms, positioning it as the most frequent lysosomal deposit disease.

This agreement marks a significant milestone for both mAbxience and Biosidus, as it represents a strategic advance in their respective areas of expertise. In addition, mAbxience strengthens its position in the CDMO sector, demonstrating its ability to collaborate in the development and manufacture of complex, high-value treatments. For Biosidus, this agreement means a significant milestone in its path to increase its impact in the global pharmaceutical industry, being the first biosimilar molecule for the treatment of a rare disease developed in Latin America and emerging markets, reinforcing its commitment to innovation and access to high quality treatments at affordable prices hand in hand with a solid industrial partner such as mAbxience.

“This agreement with Biosidus not only reflects our technical expertise and experience in CDMO and producing biopharmaceuticals, but also our commitment to improving global health through the provision of accessible and effective medicines,” said Jurgen Van Broeck, Global Commercial Director of mAbxience. “We are proud to collaborate in the manufacture of Biosidus’ Agalsidase Beta, a crucial product for those patients diagnosed with Fabry disease.”

Mariano de Elizalde, CEO of Biosidus said: “The alliance with mAbxience represents an important step in our mission to lead in the field of biotechnology in emerging markets. This agreement allows us not only to expand our product portfolio but also to bring innovative therapeutic solutions, developed with international standards of excellence and accessible in price for health systems, in the field of rare diseases.”

The agreement reinforces the vision of both companies to be leaders in the biopharmaceutical industry, combining the technical expertise and production capacity of mAbxience with the innovation and patient focus of Biosidus. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease, providing access to essential treatments in Argentina and, subsequently, in other countries around the world.

Source: mAbxience