Senate Bill 598 - which was passed by the Californian assembly in August - would have allowed physicians to insist patients use branded biopharmaceuticals rather than cheaper biosimilars and require that pharmacies notify patients when they dispense an alternative in place of an originator drug
However, on Saturday, the Bill fell at the final hurdle when State Governor Gerald Brown - though accepting and supporting its acknowledgement that approved biosimilars were interchangeable with branded biologics - returned the Bill without his signature.
The requirement for “pharmacists to send notifications back to prescribers about which drug was dispensed,” he wrote, “is for some reason highly controversial.”
He explained: “CalPERS [The California Public Employees' Retirement System] and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.”
FDA’s Authority Reinforced
His comments reinforce the FDA’s authority and though the agency told Biopharma-Reporter.com it “does not have a position on any particular state legislation,” it previously said efforts to undermine trust in biosimilars were “worrisome.”
“It is important for everyone to approach these issues with an understanding of both FDA’s expertise in this area and what the 2010 [pathway on biosimilar] law requires for approval of biosimilar and interchangeable products,” Lisa Kubaska, FDA spokesperson, told this publication in August.
The Generic Pharmaceutical Association (GPhA) welcomed Brown’s veto with President Ralph Neas saying in a statement that over 30 organisations were opposed to SB 598 and similar bills as “it adds unneeded burdens to the dispensing of biosimilar medications that will drive up costs.”
Amgen and Genentech Thwarted
Furthermore, he described this Bill as “one of a series of bills introduced across the country by giant brand biotech companies hoping to stymie competition before any biosimilar therapies are even approved,” in a direct dig at Amgen and Genentech, who have heavily lobbied the legislation across a number of States in order “to drive their profits and thwart competition.”
Neas said: “Legislation similar to SB 598 has been blocked this year in 10 states, enacted with significant amendments in three states, and enacted with Amgen and Genentech-backed provisions intact in only one state (North Dakota). Florida enacted a law that promotes access to biosimilars without burdensome physician notification requirements.”
“Disappointed”
Amgen said in a statement: “This is a missed opportunity to establish a clear, orderly system for introducing biosimilars into California law, and defining key terminology for our healthcare providers.
“The bill would have given Californians with serious illnesses increased access to biologic and biosimilar medicines in a way that maintained patient medical records and facilitated manufacturer accountability.”
Genentech spokesperson Robin Snyder added the firm was “disappointed” by the decision, telling us that without this legislation, patients may not benefit from “lower cost, FDA-approved biosimilar medicines.”
Premature Regulation?
The nature of the Bill also struck Governor Brown as “premature,” as the FDA “has not yet determined what standards will be required for biosimilars to meet the higher threshold for ‘interchangeability.’”
Snyder rebutted Brown’s comments of the Bill being premature. “Given that biosimilars may be available to patients in 2014, the state legislative initiative in California is timely and necessary.”
The FDA's Center for Drug Evaluation and Research (CDER) has received - as of June - 17 Investigational New Drug (IND) applications for biosimilar development programmes and had already received 56 meeting requests to discuss biosimilar development programs for 12 different products, Snyder said.