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Lawmakers could restrict use of most advanced drugs

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Posted: Wednesday, February 20, 2013 6:50 pm | Updated: 9:02 pm, Fri Mar 22, 2013.

State lawmakers have proposed a bill that would regulate drugs that don't exist yet. If passed, the law could someday have a big impact on the cost of treating serious illnesses, including cancer.

Some of the newest drugs don't come from combinations of chemicals. These “biologics” are made from proteins created by living cells. They're also hugely expensive, and critics of the bill that passed a state house subcommittee say it will limit use of generic equivalents, called "biosimilars," that could save patients, and taxpayers, big money.

“They want expensive brand names drugs to be used because they'll profit from that,” says Mark Merritt, President of the Pharmaceutical Care Management Association. He warns that the bill could limit availability of cheaper versions of new drugs, costing a lot of money, for no reason. “When a generic is just as good as a brand,” he says, “a patient should have access to the more affordable drugs.”

The problem with biologic drugs is proving when a substitute will work as well. “These are not chemical, they don't have a formula,” says Steven Grossman, a regulatory and policy expert who writes the blog fdamatters.com. The lack of precise formula makes biologics impossible to copy exactly. It's why the generic versions are called "biosimilars."

“As a biosimilar, there's an extra margin of uncertainty,” Grossman says. “And where we've had generic drugs on the marketplace for 25-30 years, this is a new concept.”

Grossman says the Food and Drug Administration will thoroughly vet biosimilars to make sure they work, and that they're safe, before they get to market. And that's nowhere close to happening. Drug companies who claim a public safety hazard from biosimilars made the same case against generic drugs when they first came.

“We've heard the anti-generics message from the brand industry for literally decades now,” says Merrit. “This is just the latest step in that campaign.”

He and Grossman agree that the FDA should decide whether biosimilars, and which ones, should be allowed to substitute for brand names.

Some drug companies that make generics, including Novartis, have lobbied against the bill, pushed hard by companies like Genentech, which makes the cancer fighting biologic drug Avastin.

 

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