Bill would regulate 'biosimilar' drugs

SACRAMENTO Two of the nation's largest biotech companies Amgen Inc. of Thousand Oaks and Genentech Inc. of South San Francisco are fighting in Sacramento to keep a tight grip on some of their most lucrative drugs.

At stake is a potential market worth tens of billions of dollars for pricey biological medicines they make from human blood, serums, bacterial cultures, viruses and other microorganisms. They are used to treat cancers, immune disorders and many other complex diseases.

But now other drug manufacturers want to make and sell "biosimilars." These are drugs that would be similar to biological medicines but not identical like generic drugs. These biosimilar drugs would have to be certified by the U.S. Food and Drug Administration as "interchangeable" substitutes. The FDA has not yet spelled out how this would work.

On Monday, the Senate Appropriations Committee will get a taste of the biosimilar debate. It will consider SB 598, a bill by Sen. Jerry Hill (D-San Mateo) to regulate the use of these injectable, biosimilar drugs. His legislation would enable doctors to restrict the use of biosimilars and require pharmacists to keep records of their dispensing.

Hill said it's a matter of drug safety. "SB 598 allows pharmacists to automatically substitute lower-cost biosimilar medications so patients can save money," he said. "The bill also ensures that doctors of seriously ill patients are notified if the medication is switched so the physician knows what drug their patient is taking."

Backers include some drug makers and some patient advocacy groups, doctors and high-tech companies.

Opponents say the bill would establish little more than a set of roadblocks to keep cheaper substitutes off the market in California. Regulation, they contend, should be left to the FDA. Opponents include drug firms that might make biosimilars and pharmacies as well as health insurers. Unions are on both sides of the issue.

What the bill really does is help a major employer in Hill's legislative district Genentech, a unit of Swiss drug giant Roche Holding, said Brynna Clark, senior director for state affairs at the Generic Pharmaceutical Assn. It seeks to fend off potential competition, she said. "It's about market share and patent protection."

Trade tax break

The Legislature could soon deliver $500 million worth of tax breaks for importers and exporters that boost their spending at California's seaports and airports.

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Bill would regulate 'biosimilar' drugs