Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. Section 54.1-3408.04 of the Code of Virginia permits pharmacists to dispense a biosimilar in place of a prescribed biological product only if that biosimilar meets the higher safety standards for “interchangeability” under the federal Biologics Price Competition and Innovation Act of 2009. Section 54.1-3408.04 raises additional hurdles for biosimilar and interchangeable biologic drug manufacturers by imposing recordkeeping and prescriber and patient notification requirements on a pharmacist dispensing an interchangeable biosimilar in the place of a prescribed biological product. In contrast, pharmacists are not subject to those burdens when substituting a therapeutically equivalent small-molecule generic drug for a prescribed branded drug. The provisions of the Act are discussed in more detail in a March 28, 2013 Duane Morris client alert (click here).

Virginia’s enactment of the interchangeable substitution law marked the first success by the Alliance for Safe Biologic Medicines (the Alliance), which has been urging state legislatures to adopt legislation regulating substitution of interchangeable biosimilar drugs as part of its mission to “protect patient safety and ensure the accessibility of these products.” At least 14 other states were reported to consider similar legislation, including Arizona, Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Massachusetts, North Dakota, Oregon, Pennsylvania, Texas and Washington. IN Mississippi in early 2013, a similar bill died in committee. Following Virginia’s enactment of § 54.1-3408.04, it is likely to be of interest to proponents of both the biologic product industry and biosimilar manufacturers whether other states will enact similar legislation, or whether they will follow Mississippi’s lead and reject legislation regulating interchangeable product substitution.

If you have any questions about this blog entry, please contact Vicki G. Norton, Ph.D., or the attorney in the firm with whom you are regularly in contact.