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Interchangeability of biosimilars


Over the last 15 years, a large number of so-called ‘biosimilars’ have been marketed. Biosimilars are biological drugs that have been copied from the biological reference drug after the period of market protection had ended. They are comparable to the original biologicals, but not identical. Care providers and patients have doubts about the effectiveness and safety of biosimilars compared to the original biologicals. Can the original biologicals be exchanged for the comparable biosimilars without problems? And are the various biosimilars interchangeable? 

  • Biosimilars are generally cheaper that the original biologicals.
  • For the purpose of registration, the manufacturer is obliged to show that the biosimilar is equivalent, by means of research involving direct comparison with the reference drug. In that case, exchanging a biosimilar for the reference drug will yield equal effectiveness and safety.
  • If there are multiple biosimilars of the same reference drug, these are not compared with each other. Evidence for their interchangeabiliy is then obtained by analysing the various direct comparisons with the reference drug. 
  • Since direct comparative research among biosimilars is lacking, it cannot be fully excluded that switching between biosimilars leads to undesirable immunogenicity. This risk appears small, but vigilance is warranted.

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Authors

  • Leo M.L. Stolk, dr