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Biosimiliars laboratories may also do the following tests:

  • Comparative Analytical Characterization: To demonstrate similarity in structure and function to the reference product Testing
  • Clinical Efficacy and Safety Studies: To confirm that there are no clinically meaningful differences in efficacy and safety Testing
  • Immunogenicity Testing: To assess the potential for immune response Testing
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: To compare the biosimilar's and the reference product's bioavailability and effect on the body Testing
  • Stability Testing: To ensure product quality over time Testing

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