Ustekinumab (trade name Stelara) is a human monoclonal antibody against interleukin 12 and interleukin 23, which are pro-inflammatory cytokines. Therefore, Ustekinumab is approved to treat inflammatory skin diseases such as psoriasis.

Biosimilar Characterization Considerations

The guidelines state that characterization of Utekinumab 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