Biosimilars.

The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. Among other permitted acts, a pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined, as specified, of those drug products having the same active chemical ingredients. A person who knowingly violates the Pharmacy Law is guilty of a misdemeanor, as specified. This bill would authorize a pharmacist, in his or her discretion, except as specified, to select a biosimilar, as defined, when filling a prescription order for a prescribed biological product only if the product has been approved by the federal Food and Drug Administration, as specified, and the prescriber does not personally indicate "Do not substitute," as specified. The bill would also require, for prescriptions filled prior to January 1, 2017, the pharmacy to, within 5 business days of the selection of a biological product or an interchangeable biosimilar, notify the prescriber or enter in a patient record whether the prescription dispensed was a biological product or an interchangeable biosimilar, except as specified. The bill would prohibit a pharmacist from selecting a biosimilar that meets the requirements of these provisions unless the cost to the patient of the biosimilar selected is the same or less than the cost of the prescribed biological product. The bill would also require that the substitution of a biosimilar be communicated to the patient. Because a knowing violation of these requirements would be a misdemeanor, the bill would create new crimes, thereby imposing a state-mandated local program. The bill would also require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biosimilar products determined by the federal Food and Drug Administration to be interchangeable, as specified. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.