Drug intelligence / Profile preview

XB003

Development stage
Preclinical
Lead developer
Alvotech
Modality
Fab Fragments → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

XB003 is a biosimilar drug candidate referencing Cimzia (certolizumab pegol), a tumor necrosis factor alpha (TNFα) inhibitor primarily used in the treatment of rheumatoid arthritis and psoriasis. Cimzia is also notable for its use in pregnant and breastfeeding women due to its unique molecular structure. XB003 has been developed using Xbrane's patented platform technology designed for high-yield and low-cost production. Analytical similarity to the reference product has been demonstrated, and the program is ready to initiate clinical trials as of 2025. The drug was originally developed by Xbrane Biopharma but was acquired by Alvotech in March 2025[1][2][3][4][5][9].

Other names
certolizumab pegol biosimilarCimzia biosimilar candidate
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))

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