The California State Assembly became the latest state legislature to move forward with bills that specifies requirements under which pharmacists can substitute biosimilars for brand-name products. The bill (SB-598) passed the California State Assembly on Aug. 26, 2013, and now moves to the California Senate for a final vote.
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 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 would prohibit a pharmacist from selecting a biosimilar unless the cost is the same or less than the cost of the prescribed biological product. The bill also requires that the substitution of a biosimilar be communicated to the patient.
State legislatures have become a key focal point for biosimilar as the industry waits for a final US regulatory pathway for biosimilars. The Patient Protection and Affordable Care of 2010, the landmark healthcare reform package signed into law (Public Law 111-148) by President Barack Obama on March 23, 2010, authorized a regulatory pathway for biosimilars (1). In February 2012, FDA issued three draft guidances relating to biosimilars (2-4), but these guidances have not been finalized. The approval pathway, as established by the federal law, distinguishes between biologic products that are “biosimilar” to an innovator biologic, meaning they are “highly similar” to an innovator product, and biologic products that meet a heightened standard to be deemed “interchangeable” (5). Although FDA’s role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed is governed by state law (5), and it is that issue that has been the recent focus of many state legislatures.
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, according to information from the Generic Pharmaceutical Association (GPhA). Twelve states—Arizona, Arkansas, Colorado, Delaware, Indiana, Illinois, Maryland, Mississippi, Nevada, Texas, and Washington State—have introduced but not passed such biosimilar legislation. In addition to California, such legislation is pending in Massachusetts and Pennsylvania. Legilsation bill is currently pending in Massachusetts and Pennsylvania, according to information from GPhA.
1. FDA, “Biosimilars,” www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/, accessed Apr. 10, 2013.
2. FDA, Draft Guidance for the Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Feb. 2012).
FDA, Draft Guidance for the Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Rockville, MD, Feb. 2012).
4. FDA, Draft Guidance for the Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (Rockville, MD, Feb. 2012)
5. BIO, BIO Principles on Patient Safety in the Substitution of Biologic Products (Washington, DC, Jan. 24, 2013).