BioPharmaSpec provides a complete solution for Golimumab/ Simponi comparability, biosimilarity and characterization studies.

Golimumab (trade name Simponi) is a monoclonal antibody used in the treatment of arthritis, ankylosing spondylitis and ulcerative colitis. It is a standard IgG1 antibody that, similar to Enbrel, Humira and Remicade, inhibits tumor necrosis factor alpha (TNFα). TNFα is central to the inflammatory response and plays a major role in inflammatory/ autoimmune diseases such as arthritis, plaque psoriasis and ankylosing spondylitis. Golimumab is therefore used to treat certain inflammatory diseases due to this ability to inhibit TNFα.

Biosimilar Characterization Considerations

The guidelines state that Golimumab/ Simponi comparability, characterization and biosimilarity 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

  • Cell-based Neutralization Assays
  • Binding Assays – Fc, Fab
    • ELISA
    • MSD
    • BLI
  • Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
  • Complement-Dependent Cytotoxicity (CDC) Assay

Product Specific Technical Considerations

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

  1. Levels of Pyroglutamination
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation