Agalsidase Beta BS JCR
Agalsidase beta biosimilar developed by JCR Pharmaceuticals. Reference product Fabrazyme.
Brands by market: Agalsidase Beta BS [JCR] (Japan) · Commercial partner or holder: JCR Pharmaceuticals
FDAnot listed
EMAnot listed
PMDASep 2018approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan · Agalsidase Beta BS [JCR]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Agalsidase Beta BS [JCR]
Holder or applicant
JCR Pharmaceuticals
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2018
Indications as licensed
Fabry disease
Presentations
5 mg and 35 mg vials
Note
Agalsidase Beta Biosimilar 1, the only enzyme replacement biosimilar approved anywhere.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2018Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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