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 below.

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.”

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