Calif. governor vetoes biosimilars bill

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.