Biosidus Announces Promising Interim Results from Phase III Study on Agalsidase Beta for Fabry Disease

BUENOS AIRES, Argentina, April 16, 2025, an Argentinean pioneer company in biotechnology research, development, and the production of high-quality biosimilars, has announced encouraging interim results from the Phase III SMILE¹ study. After 26 weeks of treatment, the study successfully met its primary endpoint, underscoring the potential of agalsidase beta as a safe and effective biosimilar treatment for Fabry disease. The complete dataset, including final secondary objectives, is expected to be published by the first semester of 2025 and commercialization in Argentina could begin by the middle of this year.

"There are currently only two biosimilars of this product available worldwide, and we will have the first one in Argentina and the region," says Mario Koch, Commercial Operations Director for Southern Latam at Biosidus. "Our product is already approved in Argentina, but once we obtain local authorization to launch, we plan to expand to other countries. Our roadmap for the next two to four years includes strategic entry into emerging markets where Biosidus has established partnerships, with a long-term goal of reaching Europe and the United States. Our vision is to take this product from Argentina to the world."

A rigorous preclinical trial program confirmed a high degree of similarity with the reference product in all analyzed physicochemical and biological properties². Likewise, the data collected suggest that its pharmacokinetic, pharmacodynamic, immunogenic, and safety profiles could be comparable to the innovative product³. Safety data collected so far in the SMILE study, continue to support the potential of our drug to become a biosimilar treatment for Fabry disease. "This study was designed to scientifically assess the comparability of our drug with the reference innovator drug, analyzing its behavior as a biosimilar," emphasizes Dr. Viridiana Berstein, Clinical Research Manager at Biosidus.

Treatments for Fabry disease are considered high-cost, often posing a challenge to the sustainability of healthcare systems and equitable access, particularly in emerging countries. "The cost reduction from a biosimilar product, especially for a lifelong treatment, will definitely contribute to the sustainability of the system, probably reducing legal disputes and enabling access to a larger number of patients," concludes Koch.

Biosidus' commitment to global biosimilar access
With over 40 years of experience in the development, production, and commercialization of biosimilars, Biosidusremains dedicated to improving global access to high-quality treatments. Its portfolio of nine self-developed products is already exported to more than 50 countries.

Given the significant financial burden that rare disease treatments place on healthcare systems, biosimilars present a viable solution for making therapies more affordable and accessible. Currently, seven countries account for 85% of the global consumption of biologics. Biosidus is committed to narrowing this gap through an ethical and equitable approach to biosimilar distribution.

For more information about Biosidus: https://www.biosidus.com.ar/en/

Media Contact:
Mariela de la Fuente
[phone]
[e-mail]

^{______________________________}

_{¹Switch Over Study of Biosimilar AGA for Fabry Disease³ Berstein et al. Comparative pharmacokinetics and pharmacodynamics of two formulations of agalsidase beta. Mol Genet Metab Rep. 2024 Oct 7:41:101149. Available at: https://www.sciencedirect.com/science/article/pii/S2214426924001022}