Biosidus, an Argentinian biotechnology company, announced positive interim Phase III trial results for its agalsidase beta biosimilar for Fabry disease. The study met its primary endpoint after 26 weeks, demonstrating the treatment’s safety and efficacy. Full results are expected in the first half of 2025, with potential Argentinian commercialization by mid-2025.
This successful trial is particularly important because it offers a potentially more affordable treatment option for Fabry disease, a rare genetic disorder. High treatment costs often limit access, especially in emerging markets. A biosimilar version could significantly improve affordability and patient access, easing the financial strain on healthcare systems. This also positions Biosidus to compete in a market currently dominated by only two other biosimilars globally.
Preclinical studies have shown the Biosidus biosimilar to be highly similar to the reference product in its physicochemical and biological properties. Furthermore, data suggest comparable pharmacokinetic, pharmacodynamic, immunogenic, and safety profiles to the existing treatment. The ongoing Phase III trial reinforces this safety profile.
This positive interim data is a crucial step for Biosidus. It paves the way for potential commercialization in Argentina and expansion into other emerging markets, aligning with the company’s goal of broader biosimilar access. Future success hinges on securing regulatory approvals and demonstrating the drug’s long-term efficacy and safety. Ultimately, this development represents a significant advancement in expanding access to potentially life-altering treatment for Fabry disease patients globally.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
