Drug intelligence / Profile preview

MabionCD20

Development stage
Phase 3
Lead developer
Mabion
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**MabionCD20** is a biosimilar to rituximab, a chimeric monoclonal antibody targeting CD20 on B-lymphocytes. It induces B-cell depletion through mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and CD20-directed cytolytic effects, similar to the reference product MabThera/Rituxan. Developed by Polish biotech company **Mabion SA**, it has been evaluated in Phase 3 trials for **CD20-positive diffuse large B-cell lymphoma (DLBCL)** and **rheumatoid arthritis (RA)**, with bridging studies ongoing for EMA and FDA approval. EMA marketing applications were withdrawn in 2020 to refine strategy, while FDA feedback supports US registration using EU data; it also received orphan drug designation for **membranous nephropathy**.

Brand names
MabionCD20MabionCD-20MabionCD 20
Other names
Mabion CD20Rituximab MabionMABIONCD-20MABIONCD20MABIONCD 20
02

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