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:
Functional Testing by Custom Biologics
- IL-6R Binding Assays
- Neutralization Assays
- Classical/Trans Signaling IL-6R
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- N-terminal heterogeneity
- Disulfide bridges
- Heavy chain C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation and fucosylation)
Need Biosimilar Testing?
BioPharmaSpec scientists have provided data to support many biosimilar development programs for our global client base. Contact our scientists now to understand how we can use our protein characterization methods to accelerate the development of your molecule.