Aflibercept (trade name Eyelea)  inhibits vascular endothelial growth factor VEGF, due to being a fusion protein of the VEGF binding portions of VEGF receptors 1 and 2 and the Fc portion of IgG1.

Biosimilar Characterization Considerations

The guidelines state that characterization of Aflibercept 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. Disulfide bridges
  2. C-terminal Lysine
  3. Glycosylation (in particular galctosylation and fucosylation levels and glycosylation site profiling and occupancy assessment)
  4. Deamidation
  5. Oxidation