Switch Over Study of Biosimilar AGA for Fabry Disease

Inclusion Criteria: Sex and Age

1. Male or female participant with ≥18 and ≤60 years of age at the time of signing theinformed consent form (ICF). Reproduction
2. Female participants who are not pregnant, breastfeeding, donating eggs (ova, oocytes),or considering becoming pregnant during the study and for 3 months after the last doseof study treatment.
3. All women of childbearing potential (WOCBP) must have a negative urine pregnancy testat the Screening visit and at Baseline visit (prior to the first dose of experimentalintervention).
4. WOCBP must use one highly effective form of birth control contraception through thestudy and for 3 months after the last dose of study treatment (refer to Appendix 1 inSection 10.1).
5. Male participants who are not considering fathering a child during the study and for 3months after the last dose of study treatment.
6. Male sexually active participant with female partner(s) of childbearing potential mustagree to use male condoms during the study and for 3 months after the last dose ofstudy treatment or have documented successful surgical sterilization. Informed Consent
7. Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol. Type of Participant and Characteristics
8. Confirmed previous diagnosis of FD.
9. Women: preferably present genetic testing showing pathogenic GLA mutationconsistent with FD at screening.
10. Men: preferably present leukocyte α-Gal A activity below normal range and/ orpathogenic GLA mutation consistent with FD at screening.
11. At least 50% of the participants will be male with classic FD phenotype. Theremaining percentage will consist of male late onset and classic women FDphenotype.
12. Participants who have been on stable Fabrazyme® treatment for at least 6 months priorto Baseline visit.
13. Patients that in the last 3 months before the baseline visit have been receiving ≥80%of Fabrazyme®'s labeled dose/kg, this calculation includes both infusions provided byBiosidus during the Lead in period.
14. Disease status considered clinically stabilized, at Investigators' discretion.
15. Estimated glomerular filtration rate (eGFR) ≥45 mL/minute/1.73 m2 by CKD-EPI equationat Screening visit.
16. If receiving pain killers, angiotensin-converting enzyme (ACE) inhibitors orangiotensin II receptor blockers (ARBs), participants must be in a stable dose for ≥ 4weeks.

Exclusion Criteria: Medical Conditions

1. Chronic kidney disease in stage 3b, 4, or 5.
2. History of dialysis, kidney transplant or participants who are on the waiting list fora kidney transplant.
3. Proteinuria ≥1 g/day at screening.
4. Participants who have suffered a clinical cardiovascular event (such as but notlimited to myocardial infarction, transient ischemic attack) within 6 months prior toScreening visit.
5. Participants who have clinically significant unstable cardiac disease (such as but notlimited to uncontrolled symptomatic arrhythmia, unstable angina, congestive heartfailure New York Heart Association class III or IV).
6. Participants who have suffered a clinical cerebrovascular event (such as but notlimited to stroke, transient ischemic attack) within 6 months prior to Screeningvisit.
7. History of anaphylaxis or other type I hypersensitivity reactions to agalsidase beta.
8. History of acute kidney injury in the 12 months prior to Screening visit (such as butnot limited to acute interstitial nephritis, acute renal failure of glomerular originor caused by vasculitis).
9. Presence of any medical, emotional, behavioral, or psychological condition that,according to the Investigator, would interfere with the participant's compliance withthe requirements of the study. Prior/Concomitant Therapy
10. Treatment initiation or change of dose of ACE inhibitors or ARBs in the 4 weeks beforethe screening. Prior/Concurrent Clinical Trial Experience
11. Current participation in an interventional study, in which the participant receivedany drug within 90 days before the Screening visit.