From:  Biologics and biosimilars in musculoskeletal diseases: addressing regulatory inconsistencies and clinical uncertainty

 Factors compared between biologics and biosimilars in the FDA approval process [3, 5]

Factors compared between biologics and biosimilars
  • Sequence of amino acids

  • Potency

  • Post-translational modifications

  • Analysis of impurities

  • Binding affinity to target

  • End-product stability

  • Molecular weight

  • Delivery device

  • Antibody-dependent cell-mediated phagocytosis

  • Antibody-dependent cell-mediated cytotoxicity

  • Receptor specificity

  • Receptor binding

  • Receptor signaling

FDA: Food and Drug Administration