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aBLA Filing Intelligence & Biosimilar Opportunity

Lynozyfic

Linvoseltamab-Gcpt
Anticancer
Injection

Lynozyfic is a monotherapy for adults with relapsed and refractory multiple myeloma after ≥3 prior therapies. This bispecific T-cell engager bridges CD3 on T-cells with BCMA protein on myeloma cells to activate cancer-cell killing. FDA and EMA approved for heavily pretreated patients who have exhausted standard treatment options.

Approval Date
02-Jul-25
Data Exclusivity Expiry
02-Jul-29
Market Exclusivity Expiry
02-Jul-37
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
89
2027
170
2028
282
2029
383
2030
477
2031
570
2032
661
Molecule profile

Details & specifications

Molecule
Linvoseltamab-Gcpt
Innovator
REGENERON PHARMACEUTICALS, INC.
Dosage Form
Injection
Strength
5 mg/2 mL
Therapeutic Category
Anticancer
Usage
To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody
Good to know

Frequently asked questions

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