aBLA Filing Intelligence & Biosimilar Opportunity

Vyloy

Zolbetuximab-Clzb

Anticancer

Intravenous Infusion

Vyloy is used with fluoropyrimidine and platinum-based chemotherapy as the first-line treatment for HER2-negative gastric or gastroesophageal junction cancer, which cannot be removed by surgery or has spread and tests positive for claudin (CLDN)18.2.

Approval Date

18-Oct-24

Data Exclusivity Expiry

18-Oct-28

Market Exclusivity Expiry

18-Oct-36

Commercial snapshot

Market performance & projections

Revenue ($M)

406

CAGR (%)

24.68%

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

520

2027

676

2028

843

2029

981

2030

1,099

2031

1,218

2032

1,335

Molecule profile

Details & specifications

Molecule

Zolbetuximab-Clzb

Innovator

ASTELLAS PHARMA US, INC.

Dosage Form

Intravenous Infusion

Strength

100 mg/vial

Therapeutic Category

Anticancer

Usage

To treat gastric or gastroesophageal junction adenocarcinoma

Good to know

Frequently asked questions

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