April 22, 2019

HB 13-1121: Allowing Pharmacists to Substitute Biosimilar Drugs When Available

On January 18, 2013, Rep. Sue Schafer and Sen. Rollie Heath introduced HB 13-1121 – Concerning the Ability of a Pharmacist to Substitute a Biosimilar Product for a Prescribed Biological Product When Certain Conditions are SatisfiedThis summary is published here courtesy of the Colorado Bar Association’s e-Legislative Report.

Current law permits a pharmacist to substitute an equivalent drug product for a prescribed drug if the substituted drug is the same generic drug type as the prescribed drug, and the pharmacist determines that the substituted drug is therapeutically equivalent to and interchangeable with the prescribed drug. While a pharmacist may substitute chemical drugs, current law does not allow a pharmacist to substitute biological drug products.

The bill allows a pharmacist to substitute a biosimilar product if the federal food and drug administration (FDA) has determined the biosimilar product to be interchangeable with a prescribed biological product for the indicated use and if the practitioner has not indicated that the prescription must be dispensed as written. Once a substitution occurs, the pharmacist must notify the practitioner of the substitution, and the pharmacy from which the biosimilar product was dispensed must retain a record of the substitution for at least five years. A pharmacist may comply with the notice requirement by entering the substitution information in an electronic system between the prescribing physician and the pharmacist, including an electronic medical record. The requirement to notify the prescribing practitioner of the substitution of an interchangeable biosimilar product is repealed three years after the date on which the FDA first approves a biosimilar product as interchangeable with a specific biological product.

As with the substitution of a chemical drug, the pharmacist substituting a biosimilar product for a prescribed biological product must notify the purchaser orally and in writing and may only substitute a biosimilar product if the substituted product costs less than the prescribed biological product, unless the prescribed biological product is not in stock and the purchaser consents to the higher-priced biosimilar product.

The bill requires the state board of pharmacy to maintain a link on its web site to the FDA resource that identifies biosimilar products approved as interchangeable with specific biological products. On Feb. 26, the bill passed 3rd Reading in the House.