Pennsylvania legislation calls for patient and physician notification on biological substitution

The US state of Pennsylvania’s Senate Public Health and Welfare Committee has approved Senate Bill 405, which would require a pharmacist to notify the patient and, within 72 hours, the patient’s physician of any biologic product, or biosimilars, substitution.

The move was welcomed by the Biotechnology Industry Organization (BIO) and Pennsylvania Bio. The policies outlined in Senate Bill 405 align with BIO’s principles on biologic substitution, therefore BIO and Pennsylvania Bio encourage Pennsylvania’s Senate to support and pass this bill.

While the US Food and Drug Administration oversees approval of biologic medicines and the designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify patients and doctors is covered by state law.