Virginia Bill First to Allow Biosimilar Substitution

Published Online: Thursday, April 18, 2013
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A recently passed Virginia bill is the first of its kind allowing pharmacists to dispense biosimilar products in place of a prescribed biologic product.

The bill, signed into law by Virginia governor Bob McDonnell on March 21, allows the substitution providing the FDA has licensed the biosimilar product as interchangeable with the biologic product, and as long as the provider or patient does not object to the substitution, according to a summary of the bill.

Although the law allows substitution, it comes with several procedural requirements. Pharmacists must inform patients of the substitution prior to dispensing the product, as well as recording the brand name or product name, and the name of the biosimilar manufacturer on the record of dispensing and on the prescription label. Records of substitutions must be maintained by both pharmacist and prescriber for no less than 2 years after the dispensing date.

In addition, for the first 2 years after the bill is enacted, pharmacists must also notify the prescriber of the substitution and supply retail cost information for both the prescribed biologic product and the biosimilar substitute to the patient. The notification requirement expires July 1, 2015.

The Generic Pharmaceuticals Association (GPhA) says the bill creates too much red tape for substitution, thereby threatening the impact of biosimilars within the state, GPhA President Ralph G. Neas said in a release.

The law is also preemptive, because it passed in advance of FDA guidance on biosimilar substitution, the release said. Although the Patient Protection and Affordable Care Act covers the approval process for biosimilar products—existing laws governing the approval of generic drugs did not cover biosimilar products because very few drugs with biologic components existed when it passed—it does not handle the actual substitution of the products.

“While GPhA strenuously objects to any bill that includes barriers to biosimilar use that preempt FDA guidance, we welcome the Virginia state legislature’s understanding of the need to limit this legislation by including a 2-year ‘sunset’ clause,” Neas said in a release. “This clause means that the bill (notification provisions) will expire in 2015, likely before an interchangeable biologic is approved and available in the United States.

“This provision reflects the need to fully understand FDA guidance before instituting long-term regulations affecting biosimilar use,” the release continued. “. . . GPhA urges state legislators to reject biosimilar substitution legislation that preempts the FDA.”

According to a January 28 article appearing in the New York Times, several other states are considering biosimilar bills, though the article did not specify which states were considering the bills.

Since the Times’ article, Pennsylvania state senator Patricia Vance and Rep. Bryan Cutler introduced amendments to their state’s Generic Equivalent Drug Law to cover biosimilar products. The amendments were referred to the Pennsylvania State Senate’s Public Health and Welfare Committee and to the Pennsylvania House of Representatives’ Health Committee for consideration.

As introduced, the amendments to Pennsylvania’s law would allow biosimilar substitution only if the FDA deems a product interchangeable, and as long as the prescriber does not specify a brand name product either verbally or in writing. Patients would need to provide written consent for the substitution, and pharmacists would need to notify the prescriber of the substitution in writing no later than 72 hours after dispensing. Both the pharmacy and the prescriber would need to maintain written records of the substitution for at least 5 years.

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