Removing the Misconceptions Surrounding Biosimilar Interchangeability

The FDA has recently changed the labeling of biosimilars, removing the term “interchangeable” from the label with the following justification: “Because interchangeability pertains to pharmacy-level substitution, it is more appropriate to include information about interchangeability in the Purple Book, which may be easier to use as a pharmaceutical reference, rather than in product labeling, which is prescriber-focused” And: “Prescribers can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products”