Calif. bill to restrict biosimilars gets governor's veto

Generic drug group heralds decision; biotech groups disappointed

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

On Saturday, Gov. Jerry Brown vetoed S.B. 598, which had passed the state legislature in September with promotion from such biotech companies as Amgen and Genentech. The bill would require pharmacists to notify prescribers and patients if they had substituted a biosimilar for a branded biotech drug and prohibit them from dispensing a biosimilar if prescribers indicated "Do not substitute" on prescriptions. The bill contained a "sunset clause," meaning that it would only apply to prescriptions written before 2017.

Early on, the bill attracted opposition from such groups as the Generic Pharmaceutical Association, a Washington-based industry organization, as well as the board of the California Public Employees Retirement System, Walgreens, CVS Caremark, Kaiser Permanente, Express Scripts, the California Pharmacists Association, the California Retailers Association and others.

The GPhA heralded Brown's decision.

"This Amgen- and Genentech-promoted bill was designed to drive their profits and thwart competition from biosimilars, newer versions of biotech drugs that offer patients the promise of cutting-edge medicines without the hefty price tag," GPhA president and CEO Ralph Neas said. "But with one stroke of his pen, the governor has preserved access for millions of patients and will save California taxpayers billions of dollars."

But the Biotechnology Industry Organization, a trade group representing the companies that develop biotech drugs, said it was "disappointed" by Brown's decision.

"Biosimilars are not generics," BIO said in a statement. "Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same, hence the name 'biosimilar.'"

Another company that represents biotech companies, the California Healthcare Institute, was similarly disappointed.

"S.B. 598 would have established a responsible pathway for increased patient access to biologic medicines for life-threatening illnesses as soon as they were available in the U.S.," CHI VP government affairs Eve Bukowski said. "The governor recognized that physicians want notification on the use of biologics, but he failed to recognize that the FDA cannot affect whether physicians in California will be notified of the biologic medicines their patients receive at a pharmacy."

The Patient Protection and Affordable Care Act of 2010 contained amendments that authorize the FDA to create an abbreviated regulatory pathway for biosimilars, though the agency is still in the process of drafting regulations. Unlike generic pharmaceutical drugs, which the agency approves if their manufacturers can prove they are equivalent to the branded drugs they're based on, it has long been understood that biosimilars would have to undergo a brief clinical trial program before winning approval.


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