States are ready for the US FDA's future approval of interchangeable biosimilars. As of June 4, 44 states and Puerto Rico had enacted laws allowing pharmacies to substitute an interchangeable biosimilar in place of the prescribed biological product.
Under the federal biosimilars statute, FDA is to determine if a biosimilar meets specific standards to be deemed interchangeable, and nearly all state laws specify that such a designation is necessary for substitution. FDA has not granted this status to any of the 11 biosimilars approved to date, but it could do so within the next few years
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