Sunday, 13 October 2013
California Governor Jerry Brown Vetoes California’s Biosimilars Bill
I recently wrote about California’s Biosimilars Bill which was passed by the California Legislation. California Governor Jerry Brown vetoed the Biosimilars Bill today. The Sacramento Bee discusses the veto, here. The Bill arguably made it more difficult for a pharmacist to provide a biosimilar for a prescribed biologic, thus allowing biologic companies to place a barrier on the ease of substitution of biosimilars for biologics. The generic pharmaceutical industry as well as the California Public Employees’ Retirement System (CalPERS) opposed the legislation. The federal Food and Drug Administration also raised concerns about the Bill. The Bill was supported by the Biotechnology Industry Organization and Amgen. The Governor issued the following statement concerning the Bill:
To Members of the California State Senate:
Senate Bill 598 would effect two changes to our state’s pharmacy law. First , it would allow interchangeable “biosimilar” drugs to be substituted for biologic drugs, once these interchangeable drugs are approved by the federal Food and Drug Administration (FDA). This is a policy I strongly support.
Second, it requires pharmacists to send notifications back to prescribers about which drug was dispensed. This requirement, which on its face looks reasonable, is for some reason highly controversial. Doctors with whom I have spoken would welcome this information. CalPERS and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost effective alternatives to biologics.
The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold of “interchangeability.” Given this fact, to require physician notification at this point strikes me as premature.
For these reasons, I am returning SB 598 without my signature.Nicely done, Governor.