BioPharmaSpec provides a complete solution for Adalimumab/ Humira comparability, biosimilarity and characterization studies.

Adalimumab (trade name Humira) is a monoclonal antibody used in the treatment of arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and other inflammatory disorders. It is a standard IgG1 antibody that, similar to Enbrel, Simponi 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. Adalimumab is therefore used to treat certain inflammatory diseases due to this ability to inhibit TNFα.

Biosimilar Characterization Considerations

The guidelines state that Adalimumab/ Humira comparability 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

  • Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
  • Complement-Dependent Cytotoxicity (CDC) Assay
  • Cell Proliferation Assay
  • Annexin V Apoptosis Assay
  • Caspase 3/Apoptosis Assay
  • NFkB Reporter Assay
  • Binding Assays – TNFα, Fc gamma, FcRn, C1q
    • ELISA
    • MSD
    • BLI
  • TNFα Neutralization 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