Palivizumab (trade name Synagis) is a humanized  monoclonal antibody targeting the fusion protein of respiratory syncytial virus (RSV), preventing infection by inhibiting entry of the virus to the cell.

Biosimilar Characterization Considerations

The guidelines state that characterization of Palivizumab 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. N-terminal heterogeneity
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular galctosylation and fucosylation levels)
  5. Deamidation
  6. Oxidation