Biosimilars Handbook

State Legislation

When a patient goes to a pharmacy to pick up a prescription, a pharmacist may provide the patient with an equivalent and interchangeable generic medicine without having to consult the prescriber. This practice is called substitution. Each state has its own laws or regulation regarding the use of brand-name and generic prescription drugs, such as when a generic medication may be substituted for a brand-name medication. These laws, regulations and rules that govern the practice of pharmacy in each state are called pharmacy practice acts.

Because biosimilars were not available when generic substitution laws were developed, states must continue to update their pharmacy practice acts to allow for substitution of interchangeable biologic products.

Policy decisions being made today at the state and federal levels and through regulation about biosimilars must be grounded in science. These policies will create a market dynamic that influences biosimilar development and competition for years to come.

FDA-approved generic prescription drugs have produced more than $1 trillion in savings to state and federal health care programs over the past decade. As state legislatures look for ways to rein in health care costs, they can be assured that the potential savings from biosimilar medicines will also ease the strain on state health budgets and benefit patients and taxpayers alike.