State legislation on biosimilar substitution (Part 2 of 5)
The rules for drug substitution are governed by state law. Each state has regulations that determine when and how generic drugs may be substituted for brand drugs. Similarly, regulations around the substitution of biosimilars for reference biologics vary from state to state. Due to the complex nature of biologic manufacturing process, identical “generics” of biologics are not possible. While the FDA defines the interchangeability of a biosimilar, states’ laws govern whether interchangeable biosimilars can be automatically substituted by a pharmacist(1).
Since 2013, 49 states and Puerto Rico have enacted state legislations to address biosimilar substitution(1).
States that Enacted Legislation to Address Biosimilar Substitution
In 2020, District of Columbia enacted a law to authorize licensed pharmacists to dispense interchangeable biosimilar products (2), leaving Oklahoma the only state without any legislations regarding biosimilar substitution. For most states that have enacted biosimilar laws, once an interchangeability designation is granted by the FDA, a biosimilar may be substituted for the reference biologic by a licensed pharmacist. There are, however, some caveats on whether a provider prescribing the reference biologic needs to be notified of the substitution or not(1).
Biosimilar legislations vary state by state, but there are some main features that most states have in common. A summary of these features in state legislation enacted from 2013-2018 is presented below:
Features of State Biosimilar Substitution Legislation
FDA Approval: Any biological product under consideration for substitution must first be approved as "interchangeable" by the FDA.
Prescriber Decides: The prescriber (such as a physician, oncologist, physician assistant, etc.) would be able to prevent substitution by stating “dispense as written” or “brand medically necessary.”
"Notification" vs "Communication": the prescriber "must be notified" of any allowable substitution made at a pharmacy.
Patient Notified: The individual patient must be notified that a substitute or switch has been made.
Records: The pharmacist and the physician must retain records of substituted biologic medications for a certain period of time, typically two or three years.
Web Lists: The state must maintain a public or web-based list of FDA approved interchangeable products.
Features of State Biosimilar Substitution Legislation and Number of States who Enacted
The increasing number of state laws on biologic substitution is a result of increased interest in biosimilar utilization. These legislations are a step in the positive direction for biosimilar uptake. Providing guidance for healthcare stakeholders when considering alternative biosimilars is crucial for uptake.