aBLA Filing Intelligence & Biosimilar Opportunity

Elfabrio

Pegunigalsidase Alfa-Iwxj

Antimetabolic Disorder

Injection

Elfabrio is the first PEGylated enzyme replacement therapy approved by the FDA for adults with Fabry disease. It provides exogenous alpha‑galactosidase A to reduce globotriaosylceramide accumulation and improve organ function.

Approval Date

09-May-23

Data Exclusivity Expiry

09-May-27

Market Exclusivity Expiry

09-May-35

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

2027

2028

2029

2030

2031

2032

Molecule profile

Details & specifications

Molecule

Pegunigalsidase Alfa-Iwxj

Innovator

PROTALIX BIOTHERAPEUTICS, INC.

Dosage Form

Injection

Strength

20 mg/10 mL

Therapeutic Category

Antimetabolic Disorder

Usage

To treat confirmed Fabry disease

Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Intelligence you can file on

Verified regulatory data

Milestones tracked against primary FDA sources and refreshed continuously.

Analyst-built projections

Seven-year sales outlooks modeled by our pharma intelligence team.

First-to-file focus

Exclusivity windows framed around the decisions generics teams actually make.

Partnership on demand

From API sourcing to dossier support — one request starts the conversation.