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US law lets a pharmacist swap an 'interchangeable' biosimilar without asking the prescriber, but earning that label used to need costly switching studies; the FDA now says those are usually unnecessary, which should be made permanent for cancer antibodies.
Interchangeability is a US-only regulatory status that allows pharmacy-level substitution. Historically it required dedicated switching studies, which delayed and added cost to biosimilar programmes. In 2024 the FDA issued draft guidance stating that switching studies are generally not needed to demonstrate interchangeability. Finalising that position and applying it to the oncology antibodies would remove a barrier to automatic substitution in the 40-plus states whose pharmacy laws recognise the status.
Shares European Medicines Agency, FDA Oncology Center of Excellence.
Shares Regulatory divergence between regions, Prices and value.
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares Regulatory divergence between regions, Prices and value.
Shares Biosimilar, Prices and value.
Shares Biosimilar, Prices and value.
Shares Biosimilar, Prices and value.
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.