Biosimilars are approved biologics that have been demonstrated to be highly similar to a reference medicine.

A biosimilar is a biological medicine with comparable quality, safety and efficacy to a reference medicine.

Comparison – biosimilars

Key requirements for biosimilarity

  • Identical/similar structure and function
    • Identical primary structure (amino acid sequence)
    • Similar higher-order structure
    • High quality Same biological functions
  • Equivalent PK/PD
  • Comparable clinical efficacy and safety
  • Same presentation, dose (strength) and administration mode

References