The FDA's new ruling on switching studies: Will there be a rise in interchangeable biosimilars?
By Dr Nicola Davie
Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA.
When a biosimilar is designated as ‘interchangeable’ within the USA it can be substituted for the reference drug at a pharmacy without a prescription from the healthcare provider. Therefore, interchangeability designations can enhance the adoption of a biosimilar. However, to acquire this status, biosimilars must demonstrate evidence beyond structural/functional biosimilarity, safety and efficacy. To date, only three interchangeables have been approved by the Food and Drug Administration (FDA).
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