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 characterization of Golimumab 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. N-terminal heterogeneity
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular galctosylation and fucosylation levels)
  5. Deamidation
  6. Oxidation