Elsevier

Drug Discovery Today

Volume 24, Issue 10, October 2019, Pages 1963-1967
Drug Discovery Today

Feature
Are we ready to close the discussion on the interchangeability of biosimilars?

https://doi.org/10.1016/j.drudis.2019.06.016Get rights and content
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Highlights

  • There are different regulatory approaches toward interchanging biosimilars.

  • Blinded clinical studies do not reflect switching in clinical practice.

  • Current data do not indicate any switching-related adverse events.

  • Nocebo effects are a key driver for observed differences in discontinuation rates.

  • Patients and physicians should be confident that interchanging biosimilars is safe.

Since the introduction of the first biosimilar the discussion about their interchangeability has persisted. The body of evidence gathered for biosimilars provides reassurance that they are approved based on a rigorous comparability exercise and do not show clinically meaningful differences to their reference products. There are no data suggesting that the risk of switching to a biosimilar in terms of increased immunogenicity is greater than switching between two batches of any biologic. The key concern around switching biosimilars is the nocebo effect, which reinforces the need for physician involvement when switching. Whereas this might argue against automatic substitution of biosimilars, it is not a biosimilars-specific concern. To increase physician confidence in biosimilars, regulators should acknowledge that biosimilars are interchangeable.

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