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aBLA Filing Intelligence & Biosimilar Opportunity

Lunsumio

Mosunetuzumab-Axgb
Anticancer
Injection Injectable

Follicular lymphoma relapses repeatedly, and each line of therapy narrows the options that remain. Lunsumio (mosunetuzumab) brought off-the-shelf T-cell engagement to that setting.

It binds CD20 on lymphoma cells and CD3 on T cells, redirecting the immune system to destroy them. Given as a fixed-duration intravenous course with step-up dosing, it treats adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma, after two or more lines of systemic therapy.

Its accelerated approval remains ongoing. The fixed-duration, treatment-free-interval design differentiates it from continuous therapy and from CAR-T manufacturing requirements, while competition from other CD20 bispecifics makes outpatient step-up feasibility a key practical differentiator.

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

Market performance & projections

Revenue ($M)
137
CAGR (%)
43.57%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
230
2027
349
2028
465
2029
582
2030
723
2031
834
2032
943
Molecule profile

Details & specifications

Molecule
Mosunetuzumab-Axgb
Innovator
GENENTECH, INC.
Dosage Form
Injection Injectable
Strength
5 mg/0.5 mL, 1 mg/mL, 45 mg/mL, 30 mg/30 mL
Therapeutic Category
Anticancer
Usage
To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma
Good to know

Frequently asked questions

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