Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar automatic substitution laws, including, for example, New Jersey and Oregon.
Under the new Arizona law, from December 31, 2016 onward, a pharmacist is permitted to substitute a biosimilar when:
- the FDA has deemed the drug an “interchangeable biological product” as defined in 42 U.S.C. §262(k)(4);
- the prescribing doctor does not prohibit the substitution;
- the patient or person submitting the prescription is notified of the substitution;
- within five business days of making the substitution, the pharmacist records which specific product was dispensed, including the name of the product and the manufacturer, and communicates this information to the prescribing doctor; and
- the pharmacy retains a record of the dispensed biosimilar for seven years.
Arizona’s law also requires a pharmacist to provide the person submitting the prescription for a biologic with the price difference between the prescribed biologic and its interchangeable biosimilar when 1) the prescribing doctor does not prohibit substitution and 2) the transaction is not subject to third-party reimbursement.
Big Molecule Watch will continue to track the spread of automatic substitution laws in the U.S.