Mixed industry views on Virginia's law on biosimilar substitutions

25 March 2013

New legislation in the US state of Virginia signed into law last week by Governor Bob McDonnell - designed to address the regulatory issues related to the interchangeability of biological medicines - forbids pharmacists from dispensing a biosimilar substitution to a brand-name biologic drug if the prescribing physician specifies the prescription must be dispensed as written or if a patient wants the branded drug.

Pharmacists must inform the patient before dispensing a biosimilar and must note the product name and manufacturer on the prescription label and dispensing record. Pharmacists also must give patients cost information on the branded and biosimilar products under the law, which would remain in effect until 2015.

Commenting on the move, the Biotechnology Industry Organization commends the Virginia Governor for his action, saying that the policies outlined in identical House Bill 1422 and Senate Bill 1285 align with all five of BIO’s principles on biologic substitution.

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