Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease

Inclusion Criteria

• •Sex and Age
• •1. Male or female participant with ≥16 and ≤60 years of age at the time of signing the informed 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 dose of study treatment.
• •3. All women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening visit and at Baseline visit (prior to the first dose of experimental intervention).
• •4. WOCBP must use one highly effective form of birth control contraception through the study and for 3 months after the last dose of study treatment.
• •5. Male participants who are not considering fathering a child during the study and for 3 months after the last dose of study treatment.
• •6. Male sexually active participant with female partner(s) of childbearing potential must agree to use male condoms during the study and for 3 months after the last dose of study treatment or have documented successful surgical sterilization.
• •7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• •8. Confirmed previous diagnosis of FD.
• •1. Women: preferably present genetic testing showing pathogenic GLA mutation consistent with FD at screening.
• •2. Men: preferably present leukocyte α-Gal A activity below normal range and/ or pathogenic GLA mutation consistent with FD at screening.
• •3. Male with classic FD phenotype, female with classic FD and men with late onset may be included.
• •9. Participants who have been on stable Fabrazyme® treatment for at least 6 months prior to Baseline visit.
• •10. 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 by Biosidus during the Lead in period.
• •11. Disease status considered clinically stabilized, at Investigators' discretion.
• •12. Estimated glomerular filtration rate (eGFR) ≥45 mL/minute/1.73 m2 by CKD-EPI equation at Screening visit.
• •13. If receiving pain killers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), participants must be in a stable dose for ≥ 4 weeks.