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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2018approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Agalsidase Beta BS JCR
Agalsidase Beta BS JCR is the only biosimilar of an enzyme replacement therapy approved anywhere in the world, approved in Japan in September 2018 for Fabry disease. JCR developed it in Kobe and has not filed it elsewhere.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
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
Remarks
Agalsidase Beta Biosimilar 1, the only enzyme replacement biosimilar approved anywhere.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Same developer, other molecules
Other biosimilars in the Atlas developed by JCR Pharmaceuticals: Darbepoetin Alfa BS JCR, Epoetin Alfa BS JCR.
Chronology
- PMDASep 2018Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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