Indiana establishes rules for the substitution of interchangeable biologic medicines

INDIANAPOLIS — Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports. 

The bill allows a pharmacist to substitute an interchangeable biosimilar product for a prescribed biological product if certain conditions are met. It requires the board of pharmacy to maintain a website that lists the biosimilar biological products that are determined to be interchangeable. 

The specific conditions include: 

• The biosimilar product has been determined by the Food and Drug Administration to be interchangeable with the prescribed biological product;


• The prescribing practitioner has, for a written prescription, signed on the line under which the words "may substitute" appear, or for an electronically transmitted prescription, electronically transmitted the instruction "May substitute.";


• The pharmacist must inform the customer of the substitution;


• The pharmacist must notify the prescribing practitioner within five calendar days of the substitution; and


• The pharmacy and the prescribing practitioner must retain a written or electronic record of the interchangeable biosimilar substitution for at least five years.