Virginia Enacts Nation’s First Biosimilar Substitution Law

On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation's first state law concerning substitution of biosimilars. The law's requirements that pharmacists keep records of substitutions, give notice of substitution to prescribers, and give notice of retail cost to patients differ significantly from the state's existing law applicable to substitution of small-molecule drugs. The biosimilar substitution provisions requiring notice to prescribers and notice of retail cost expire in July 2015. A copy of the law as passed is available here.

The biosimilar substitution provisions permit pharmacists to dispense a biosimilar in place of a prescribed biological product, but only if the biosimilar meets the safety standards for interchangeability pursuant to federal law. This provision is similar to the requirement that a substituted chemical drug be "therapeutically equivalent" to the prescribed drug. Under Virginia law, therapeutically equivalent drug products are those that contain the same active ingredient, are identical in strength or concentration, dosage form, and route of administration, and are classified as "therapeutically equivalent" in FDA's "Orange Book."

Substitution of an interchangeable biosimilar for a prescribed biological product, or a therapeutically equivalent chemical drug for a prescribed drug, is prohibited if the prescriber has specified "brand medically necessary" on the prescription or if the prescriber has given specific oral dispensing instructions. Substitution is also prohibited if the patient "insists" on the dispensing of the prescribed biological product or chemical drug.

The biosimilar substitution provisions are similar to the small-molecule drug substitution provisions in other ways, as well. In both cases, the pharmacist must inform the patient of the substitution. Pharmacists must also indicate in their records and on the "prescription label" the name of the manufacturer or distributor of the interchangeable biosimilar or generic drug. In the case of an interchangeable biosimilar, the pharmacist must also include the "product name." In addition, the name of a...