U.S. License Holder:
Genyzme
Date of License:
April-24-2003
Last Update:
January-08-2021
FDA-Approved Indications
FABRAZYME (agalsidase beta) is indicated for use in patients with Fabry disease. Fabrazyme reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Japan
Agalsidase Beta BS (JCR Pharmaceuticals) (November-2018)