Biosidus, an biotech pioneer in the field of biosimilars, has officially launched Agalzyme for Fabry disease in the country. The product will compete head-to-head with the French drugmaker Sanofi’s Fabrazyme. A launch event in Buenos Aires convened nephrologists, cardiologists and other specialists.
Today we’re going to learn the secrets of a biosimilar molecule that will change history and the quality of life of people with Fabry disease. That’s how journalist Guillermo Lobo opened an event held by the Argentine drugmaker Biosidus at the Escondida de Dorrego in the capital Buenos Aires to raise the curtain on what is the company’s 10th biosimilar.
Biosidus’s Agalzyme is the first biosimilar from an emerging market for Fabrazyme, a brand owned by the French drugmaker Sanofi. The product is indicated for Fabry disease, a genetic disorder stemming from a deficiency in the lysosomal enzyme alpha-galactosidase A that disrupts glycosphingolipid metabolism.
With plans to export to multiple countries from Argentina, today’s launch was a major milestone and the result of a vision that involved 10 years of research and development backed by a US$ 23 million investment.
At the launch event, a packed agenda of speakers spoke on stage before an audience of nephrologists, cardiologists, adult and pediatric neurologists, as well as executives from the Argentine regulator ANMAT, research scientists and Biosidus’s entire team.
To emphasise the importance of the development, the first to speak was Biosidus CEO Mariano de Elizalde, who spoke of the company’s history of more than 40 years in biotechnology. As for Agalzyme, the executive noted that work began a decade ago and that the initial phase was led by a large team of scientists and technicians.
The company’s top executive emphasised that Argentina is a country that welcomes top-level scientists every year, and many of them joined the project. He also emphasised that all levels of the company had an impact on the project and praised shareholders for their commitment to Argentina, where support for long-term projects is vital.
Next up was Medical Director Hugo Sotelo, who described how the causes of mortality have changed over a century, with rare diseases becoming increasingly pertinent. Sotelo explained how the prescription of biologics is advancing worldwide, noting the urgent need for advances in biosimilars to lower costs for healthcare systems and to expand patient access.
Afterwards, R&D Manager Mariana Papouchado gave a highly technical talk about the biosimilar’s development, and Clinical Research Manager Viridiana Berstein elaborated on the work after clinical trials began and the high expectations placed on the process. Closing the discussion, Juan Manuel Politei gave details on Phase III and described the implementation and adherence.
Towards the end of the meeting, Guillermo Battolla, Director of Human Resources and Corporate Affairs, spoke of how the event demonstrated that Argentina has the potential, talent and sensitivity to deliver major improvements, not only for patients in the country, but also in the rest of the world. He noted that the expectation is for Agalzyme to reach the 50 countries in the developing world where Biosidus operates. There are also plans to reach Europe and the United States.
Finally, Mario Koch, Director of Commercial Operations, spoke of his close involvement with rare diseases since 2003. He said he was pleased to see that the entire project was carried out in Argentina, making it a source of great pride. He extended his gratitude to patients, the diagnostic laboratories and all those who are part of the scientific-industrial ecosystem.
