BioPharmaSpec provides a complete solution for Cetuximab/ Erbitux comparability, biosimilarity and characterization studies.

Cetuximab (trade name Erbitux) is a chimeric monoclonal antibody that inhibits epidermal growth factor receptor (EGFR) and is administered for the treatment of various cancers including colorectal, non-small cell lung and head and neck.

Biosimilar Characterization Considerations

The guidelines state that Cetuximab/ Erbitux comparability and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:

Structural Characterization

Physicochemical Characterization

Product Specific Technical Considerations

Particular attention should be paid to the Post Translational Modifications (PTMs) including:

  1. Levels of Pyroglutamination
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation