aBLA Filing Intelligence & Biosimilar Opportunity

Zynyz

Retifanlimab-Dlwr

Anticancer

Intravenous Injection

Zynyz is the first PD‑1 inhibitor approved by the FDA for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. It is now available both as monotherapy and in combination with platinum‑based chemotherapy, and is also approved for metastatic Merkel cell carcinoma; it enhances T‑cell activity to target and slow tumor growth.

Approval Date

22-Mar-23

Data Exclusivity Expiry

22-Mar-27

Market Exclusivity Expiry

22-Mar-35

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

0.4024

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

138

2027

185

2028

245

2029

294

2030

332

2031

362

2032

384

Molecule profile

Details & specifications

Molecule

Retifanlimab-Dlwr

Innovator

INCYTE

Dosage Form

Intravenous Injection

Strength

500 mg/20 mL

Therapeutic Category

Anticancer

Usage

It is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

Good to know

Frequently asked questions

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Analyst-built projections

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

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