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SB 537 / HB 733

2015 Session: Convene: 1/14/15 and Adjourn: 4/13/15

Maryland House Committee on Health and Government Operations held its hearing on the bill on 4/2/15

3/18/15: Third reading passed (46-0) in Senate

  • Bill Information

    Defines an “interchangeable biological product” as a biological product determined to be interchangeable by FDA or a product that has been deemed therapeutically equivalent by FDA.

    Directs a pharmacist to inform each consumer of an interchangeable biosimilar and the approximate price difference compared to the biologic, except if:

    —prescriber does not prohibit substitution;

    —the pharmacy primarily serves institutional recipients; or

    —the cost of prescription is reimbursed by a third-party payer, such as an insurer.

    Directs the Board to maintain on its website a list of approved interchangeable products.

    Permits dispensing of an interchangeable biological product, provided that:

    —prescriber does not indicate that substitution is prohibited;

    —the consumer is charged less for the biosimilar than the price of the biologic;

    —pharmacist notifies the patient in writing;

    —pharmacist records the substitution; and

    —pharmacist notifies the prescriber within 5 days (under SB 537) or 10 days (under HB 733), electronically if possible (and by other means if not), except when the prescription is a refill that is unchanged from the prior filling.

    Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.

    Permits the Department (of Health and Mental Hygiene) to disqualify an interchangeable biosimilar from being used in Maryland as a substitute for a biologic, if the Department determines that the product is not interchangeable, or has negative physical or biological effect on the consumer. In making such determination, the Department must generally provide an opportunity for public comment.

  • Archive

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