aBLA Filing Intelligence & Biosimilar Opportunity

Enflonsia

Clesrovimab-Cfor

Immunomodulators

Injection

ENFLONSIA is a long-acting, preventive monoclonal antibody developed to protect infants against a broad range of respiratory syncytial virus (RSV) disease severity. This includes severe cases that may lead to hospitalization. It is the first and only RSV preventive option that offers a weight-independent, single-dose administration, simplifying protection across all infants regardless of size or gestational age. ENFLONSIA provides consistent, season-long immunity with a convenient, once-per-season approach.

Approval Date

09-Jun-25

Data Exclusivity Expiry

09-Jun-29

Market Exclusivity Expiry

09-Jun-37

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

218

2027

431

2028

572

2029

694

2030

776

2031

822

2032

894

Molecule profile

Details & specifications

Molecule

Clesrovimab-Cfor

Innovator

MERCK SHARP & DOHME LLC

Dosage Form

Injection

Strength

105 mg/0.7 mL

Therapeutic Category

Immunomodulators

Usage

To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season

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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