Cetuximab (trade name Erbitux) is a 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 characterization of Cetuximab products 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 of the heavy chain
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular galctosylation and fucosylation levels)
  5. Deamidation
  6. Oxidation