Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer
Of the nearly 40 biosimilars approved to date by the FDA, only three have won the coveted interchangeability designation so far, meaning that like small-molecule generic drugs, they can be substituted at the pharmacy counter without the intervention of the prescriber.
Interchangeable biosimilars have been limited so far, as the FDA has made clear that in order to obtain this designation, sponsors have to meet additional requirements that other biosimilars don’t have to meet, including so-called switching studies where sponsors show that the risk of diminished efficacy or safety from switching between a biosimilar and its reference product “is not greater than the risk of using the reference product without such alternation or switch.”
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