BioPharmaSpec provides a complete solution for Omalizumab/ Xolair comparability, biosimilarity and characterization studies.

Omalizumab (trade name Xolair) is an IgG1 monoclonal antibody that binds to free immunoglobulin E (IgE) in blood and interstitial fluid and to membrane-bound IgE on the surface of IgE-expressing B lymphocytes. Due to the role IgE plays in allergic diseases, Xolair is used to treat cases of severe asthma where there is no response to high doses of corticosteroids. The patents on Xolair expired in the US in June 2017 and in Europe in August 2017.

Biosimilar Characterization Considerations

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

Structural Characterization

Physicochemical Characterization

Functional Testing by Custom Biologics

  • Mediator-Release Assay
  • Receptor Binding Assay
  • Affinity Binding Assay

Product Specific Technical Considerations

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

  • Levels of Pyroglutamination
  • Disulfide bridges
  • Heavy chain C-terminal Lysine
  • Glycosylation (in particular, levels of galactosylation and fucosylation levels)
  • Deamidation
  • Oxidation