Bevacizumab (trade name Avastin) is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a crucial component in the stimulation of angiogenesis (the growth of new blood vessels) in diseases including cancer. Bevacizumab is therefore an anti-cancer drug, acting as an angiogenesis inhibitor to slow the growth of new blood vessels.

Biosimilar Characterization Considerations

The guidelines state that characterization of Bevacizumab 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