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aBLA Filing Intelligence & Biosimilar Opportunity

Opdualag

Nivolumab And Relatlimab-Rmbw
Anticancer
Intravenous Solution

PD-1 and CTLA-4 blockade defined melanoma immunotherapy, and LAG-3 was the third checkpoint to be validated clinically. Opdualag (nivolumab and relatlimab) delivered it.

Pairing nivolumab with relatlimab, the first LAG-3 blocking antibody approved, it releases two independent brakes on exhausted T cells at once. The fixed-dose intravenous combination treats unresectable or metastatic melanoma in patients 12 years and older.

Opdualag showed improved progression-free survival over nivolumab alone with less toxicity than nivolumab plus ipilimumab, positioning it as a tolerability-driven first-line melanoma option. As a biologic with no biosimilar competition, it is the validating asset for the LAG-3 checkpoint class.

Approval Date
18-Mar-22
Data Exclusivity Expiry
18-Mar-26
Market Exclusivity Expiry
18-Mar-34
Commercial snapshot

Market performance & projections

Revenue ($M)
1,185
CAGR (%)
9.83%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
1,374
2027
1,528
2028
1,646
2029
1,724
2030
1,786
2031
1,836
2032
1,876
Molecule profile

Details & specifications

Molecule
Nivolumab And Relatlimab-Rmbw
Innovator
E.R. SQUIBB & SONS, L.L.C.
Dosage Form
Intravenous Solution
Strength
240 mg
Therapeutic Category
Anticancer
Usage
To treat unresectable or metastatic melanoma
Good to know

Frequently asked questions

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