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 characterization of Adalimumab products should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:

Structural Characterization

Physicochemical Characterization

Product Specific Technical Considerations

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

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