Calif. governor vetoes biosimilars bill
California Governor Jerry Brown gave biosimilar lobbyists pause last week when he vetoed a bill that would have required pharmacists to let doctors know when a biosimilar had been provided in lieu of a biologic.
The governor wrote in his rejection of Senate Bill 598 that although he supports the ability to substitute biosimilars for biologics as long as the FDA considers them to be interchangeable, the legislation is premature because the FDA “has not yet determined what standards will be required for biosimilars to meet the higher threshold for ‘interchangeability.'”
Brown also noted that doctors have told him they'd like a notice about when and if a biosimilar were substituted for a biologic, calling the proposed requirement “for some reason highly controversial.”
Pharmalot's Ed Silverman writes that although California is not the first state to kick around proposed biosimilar legislation, the Golden State's position was of particular note because it is home base to anti-substitution forces Amgen and Genentech and because it's considered a trendsetter for pharmaceutical practices.
The FDA is still hashing out biosimilar requirements, and BioCentury noted in August that state efforts to create a distinct set of rules before there is a regulatory framework could damage the biosimilar industry by undermining patient confidence in products which are not yet on the market.