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aBLA Filing Intelligence & Biosimilar Opportunity

Rybrevant

Amivantamab-Vmjw
Anticancer
Injection Injectable

EGFR exon 20 insertion mutations resist conventional EGFR inhibitors, leaving a subset of lung cancer patients with few targeted options. Rybrevant (amivantamab) was built to reach them.

Amivantamab binds both EGFR and MET, blocking parallel growth signals while also recruiting immune effector cells to the tumor. The intravenous bispecific antibody was first approved for advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after platinum-based chemotherapy.

Rybrevant’s original accelerated approval has since converted to full approval, and it has expanded into first-line EGFR-mutant NSCLC in combination regimens. As a biologic with no biosimilar competition, it is a central comparator in EGFR-driven lung cancer and a cornerstone oncology asset for its developer.

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

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
108
2027
183
2028
247
2029
287
2030
324
2031
353
2032
374
Molecule profile

Details & specifications

Molecule
Amivantamab-Vmjw
Innovator
JANSSEN BIOTECH, INC.
Dosage Form
Injection Injectable
Strength
350 mg/7 mL (50 mg/mL)
Therapeutic Category
Anticancer
Usage
To treat a subset of non-small cell lung cancer
Good to know

Frequently asked questions

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