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aBLA Filing Intelligence & Biosimilar Opportunity

Nexviazyme

Avalglucosidase Alfa-Ngpt
Antimetabolic disorder
Injection Injectable

Enzyme replacement transformed Pompe disease, but the original therapy reached skeletal muscle inefficiently, limiting benefit for patients with predominantly muscular disease. Nexviazyme (avalglucosidase alfa) was engineered to improve that delivery.

It carries roughly fifteen-fold more mannose-6-phosphate than the earlier enzyme, improving uptake into muscle cells where it clears the glycogen accumulation caused by acid alpha-glucosidase deficiency. Infusions are given every two weeks to patients 1 year and older with late-onset Pompe disease.

Nexviazyme is its developer’s designated successor to alglucosidase alfa and faces no biosimilar competition, but it now competes with an alternative two-component therapy approved later. Converting established patients off the older enzyme is the central commercial dynamic.

Approval Date
08-Jun-21
Data Exclusivity Expiry
08-Jun-25
Market Exclusivity Expiry
08-Jun-33
Commercial snapshot

Market performance & projections

Revenue ($M)
891
CAGR (%)
8.44%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
997
2027
1,094
2028
1,170
2029
1,232
2030
1,292
2031
1,348
2032
1,404
Molecule profile

Details & specifications

Molecule
Avalglucosidase Alfa-Ngpt
Innovator
GENZYME CORPORATION
Dosage Form
Injection Injectable
Strength
100 mg
Therapeutic Category
Antimetabolic disorder
Usage
To treat late-onset Pompe disease
Good to know

Frequently asked questions

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