BioPharmaSpec provides a complete solution for Tocilizumab/ Actemra comparability, biosimilarity and characterization studies.

Tocilizumab (trade name Actemra) is a humanized monoclonal antibody which targets the interleukin-6 receptor (IL-6R). The cytokine IL-6 mediates inflammation and immune response and therefore elevated levels of IL-6 can often be found in autoimmune/ inflammatory diseases including rheumatoid arthritis, multiple myeloma and prostate cancer. Tocilizumab is used as a treatment in these disease cases as it prevents IL-6 from binding to its receptor.

Biosimilar Characterization Considerations

The guidelines state that Tocilizumab/ Actemra comparability and characterization 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

  • IL-6R Binding Assays
    • ELISA
    • MSD
    • BLI
  • Neutralization Assays
    • Classical/Trans Signaling IL-6R

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, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation