Fabagal® (Agalsidase beta) — Competitive Intelligence Brief

Fabagal® (Agalsidase beta) (Fabagal® (Agalsidase beta)) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Enzyme replacement therapy (ERT). Area: Rare genetic disease / Lysosomal storage disorder.

phase 3 Enzyme replacement therapy (ERT) α-galactosidase A (GLA enzyme) Rare genetic disease / Lysosomal storage disorder Biologic

Target snapshot

Fabagal® (Agalsidase beta) (Fabagal® (Agalsidase beta)) — ISU Abxis Co., Ltd.. Agalsidase beta is a recombinant human enzyme that replaces deficient α-galactosidase A, breaking down accumulated globotriaosylceramide (Gb3) in cells.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fabagal® (Agalsidase beta) TARGET	Fabagal® (Agalsidase beta)	ISU Abxis Co., Ltd.	phase 3	Enzyme replacement therapy (ERT)	α-galactosidase A (GLA enzyme)
Fabrazyme (agalsidase beta)	Fabrazyme (agalsidase beta)	Genzyme, a Sanofi Company	marketed	Enzyme replacement therapy (ERT); recombinant enzyme	α-galactosidase A (GLA gene product); substrate: globotriaosylceramide (GL-3)
PRX-102 (pegunigalsidase alfa)	PRX-102 (pegunigalsidase alfa)	Protalix	phase 3	Enzyme replacement therapy (ERT)	α-galactosidase A (GLA)
Alglucosidase alfa (GZ419829)	Alglucosidase alfa (GZ419829)	Genzyme, a Sanofi Company	phase 3	Enzyme replacement therapy (ERT)	Acid alpha-glucosidase (GAA)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Enzyme replacement therapy (ERT) class)

1. Genzyme, a Sanofi Company · 1 drug in this class
2. ISU Abxis Co., Ltd. · 1 drug in this class
3. Protalix · 1 drug in this class