Agalsidase Beta Biosidus

Agalsidase Beta Biosidus is a recombinant human alpha-galactosidase A enzyme replacement therapy (ERT) developed by Biosidus as a biosimilar to Sanofi’s agalsidase beta (Fabrazyme) for the treatment of Fabry disease, an X-linked lysosomal storage disorder caused by deficiency of alpha-galactosidase A and accumulation of globotriaosylceramide (Gb3/GL-3) and related glycosphingolipids in multiple organs.[1][5][7][11][13][14] Produced by recombinant DNA technology, the Biosidus molecule (also referred to as AGABIO) has been shown in extensive preclinical and early clinical comparisons to be highly similar to reference agalsidase beta with respect to amino acid sequence, glycosylation patterns, lysosomal targeting, enzymatic activity, pharmacokinetics, pharmacodynamics, immunogenicity, and safety.[7][11][14] It is administered as an intravenous infusion for long-term ERT, aiming to reduce pathogenic sphingolipid deposits in kidneys, heart, vasculature, and other tissues, thereby stabilizing organ function and delaying Fabry-related renal, cardiac, and cerebrovascular complications.[1][5][7][14] Positive interim Phase III data from the SMILE study support therapeutic equivalence to Fabrazyme, and the product has been approved as the first agalsidase beta biosimilar for Fabry disease in Argentina, with plans for broader commercialization in additional markets.[2][3][5][11][13][14]

Brand names

FabrazymeReplagalBeanoGas-X PreventionCVS BeanAidEnzymedica's BeanAssistGasfixBloateez

Other names

AGABIOagalsidase beta biosimilar BiosidusBiosidus agalsidase beta