Following passage by the California Assembly in late August, the California State Senate has passed a biosimilar bill (SB-598) that specifies requirements under which pharmacists can substitute biosimilars for brand-name products. The legislation now goes to California Governor Jerry Brown for signing of the bill. The biopharmaceutical industry offered mixed views on the passage with opinion divided between the innovator-drug sector and the generic-drug sector.
The bill, which amends California’s state pharmacy law, specifies that a pharmacist filling a prescription order for a prescribed biological product may select a biosimilar only if the product is approved by FDA, has been determined to be interchangeable with prescribed biologic, and the prescriber (i.e., the doctor) does not personally indicate “do not substitute” for the product. For prescriptions filled prior to Jan. 1, 2017 for a biological product or interchangeable biosimilar, the pharmacist must notifiy the prescriber (i.e., doctor) whether the prescription dispensed was a biological product or interchangeable biosimilar or enter the information in a patient-record system shared by the prescriber. The bill also prohibits a pharmacist from selecting a biosimilar unless the cost is the same or less than the cost of the prescribed biological product. The bill further requires that the substitution of a biosimilar be communicated to the patient.
Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), issued a statement on Sept. 5, 2013 to support the action taken by the California state legislature. "I commend California's Assembly and Senate for overwhelmingly passing legislation that creates a pathway for the substitution of interchangeable biologic medicines. As the policies outlined in Senate Bill 598 align with BIO’s principles on biologic substitution, BIO supports this important legislation and encourages Governor Brown to sign the bill when it reaches his desk. BIO is pleased that the California Legislature passed this legislation and continues to put patients first,” said Greenwood.
In January 2013, BIO issued its “five principles on biologic substitution,” a framework that it recommends that states follow in adopting policy on biological substitution. The BIO principles call for substitution only when FDA has designated a biologic product as interchangeable, authorizes prescribing physicians to prevent substitution, requires both the prescribing physician and patient to be notified of substitution, and requires the pharmacist and the physician to keep records of the substitution.
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association (GPhA), voiced the group's opposition to the legislation and urged California’s governor to veto the measure in a Sept. 4, 2013 statement. "[The] Senate vote to pass SB 598 is a disappointment, not only to GPhA, but to all those who care about access to affordable medicine. The bill would create unnecessary barriers between Californians and newer, lower-cost versions of biologic therapies, known as biosimilars, particularly interchangeable biosimilars. For the sake of California patients, the California budget, and California taxpayers, GPhA calls on Governor Brown to veto SB 598."
As of August 2013, four states–Oregon, Utah, Virginia, and North Dakota, have passed legislation specifying requirements for biosimilars although the measures in Oregon, Utah, and Virginia contain sunset provisions, GPhA. Ten states—Arizona, Arkansas, Colorado, Delaware, Indiana, Illinois, Maryland, Mississippi, Texas, and Washington State—have introduced but not passed such biosimilar legislation. In addition to California, such legislation is pending in Massachusetts and Pennsylvania, according to information from GPhA. Florida is the only state to have passed a law that promotes access to biosimilars without physician notification requirements, according to GPhA.
For related stories, see the following:
California State Assembly Passes Biosimilar Legislation (Pharmaceutical Technology, Aug. 30, 2013).
State Legislatures Become Battlegrounds for Biosimilars (Pharmaceutical Technology, Apr. 11, 2013).