Is a biosimilar automatically interchangeable with the reference product?

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Interchangeability is not automatic for biosimilars. A biosimilar is highly similar to the reference biologic, but the FDA designates a separate category called “interchangeable” only after additional data show that switching between the biosimilar and the reference product does not increase risk or affect efficacy. Because not all biosimilars receive this interchangeability designation, a biosimilar cannot be assumed to be substitutable for the reference product without meeting that designation and complying with state substitution rules. In practice, pharmacists often must follow state law and obtain prescriber authorization or provide appropriate notification before substituting, even if a product is biosimilar. Therefore, a biosimilar is not automatically interchangeable.