73 Fifth, some states provide immunity to pharmacists who
comply with state law in making a substitution.
74 Sixth, some laws ask a
pharmacist to compare the cost or price of a biologic versus the
interchangeable biosimilar, and in five states, substitution is only permitted
if it would result in a prescription for a lower-cost medication.
Indiana’s recent biosimilar legislation exemplifies typical state
76 It allows a pharmacist to exchange a biologic for a biosimilar
( 1) the FDA has deemed the biosimilar to be interchangeable; ( 2) the
prescriber includes a ‘may substitute’ instruction in the prescription; ( 3)
the pharmacist informs the customer of the substitution; ( 4) the pharmacist
notifies the prescriber within five days of substitution; ( 5) a record is kept
of the substitution for at least five years.
State legislation creates controversy when it regulates “physician
notification, patient consent, documentation, and record retention.”
78 As of
March 2017, 27 states and Puerto Rico passed some form of biosimilar
substitution law governing how a prescription for a biologic might be
exchanged for an interchangeable biosimilar.
III. SELLING LEGISLATION AS “PATIENT-FRIENDLY”
Proponents of state biosimilar legislation have justified it as protecting
“patient safety . . . the physician-patient relationship” and “transparency and
communication between patients and their treatment care teams.”
proponents of state biosimilar legislation have embraced the patient-friendly
label, these proponents represent interests that are not necessarily patient-
81 A closer look at the entities and individuals supporting state
biosimilar legislation suggests that the laws may not always be designed with
patients in mind.
76. Kadin, supra note 47, at 420 (stating that Indiana legislation should be a model for
78. King, supra note 63, at 39.
79. Cauchi, supra note 68.
80. Leigh Purvis,
A Sense of Déjà Vu: The Debate Surrounding State Biosimilar
Substitution Laws, INSIGHT ON THE ISSUES, Sept. 2014, at 2,