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aBLA Filing Intelligence & Biosimilar Opportunity

Briumvi

Ublituximab-Xiiy
Immunomodulators
Intravenous Injectable

B-cell depletion became a mainstay of multiple sclerosis treatment, where infusion time and dosing convenience increasingly drive product choice. Briumvi (ublituximab) competes primarily on those terms.

Glycoengineered for enhanced antibody-dependent cytotoxicity, it achieves effective B-cell depletion at lower doses, allowing one-hour maintenance infusions twice a year. The intravenous anti-CD20 antibody treats relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Briumvi entered a market led by established anti-CD20 agents, positioning itself on shorter infusion time and price. As a biologic with no biosimilar competition, its uptake depends largely on infusion-center throughput economics and payer preference.

Approval Date
28-Dec-22
Data Exclusivity Expiry
28-Dec-26
Market Exclusivity Expiry
28-Dec-34
Commercial snapshot

Market performance & projections

Revenue ($M)
607
CAGR (%)
32.48%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
785
2027
1,069
2028
1,574
2029
1,870
2030
2,168
2031
2,473
2032
2,786
Molecule profile

Details & specifications

Molecule
Ublituximab-Xiiy
Innovator
TG THERAPEUTICS, INC.
Dosage Form
Intravenous Injectable
Strength
25 mg/mL
Therapeutic Category
Immunomodulators
Usage
To treat relapsing forms of multiple sclerosis
Good to know

Frequently asked questions

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