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NMIC Bulletin Vol. 21 No. 5 Update on biosimilar medicines

1 December, 2015

Update on biosimilar medicines

  • A biosimilar medicine is a biological medicine that is developed to be highly similar to an approved (reference) biological medicine
  • A biosimilar medicine must establish similarity to the key characteristics of the molecular and biological activity of the reference medicine
  • Biosimilar medicines are not the same as generic (chemical-based) medicines; therefore they may not be regarded as interchangeable with the reference biological medicine
  • Biological and biosimilar medicines should be prescribed by brand name to enable ongoing safety monitoring of individual medicines