FDA Decision Signals New Competition For Some Of The Costliest Drugs : Shots - Health News Drugs made from proteins or antibodies are difficult for rival manufacturers to copy. The Food and Drug Administration just approved a copycat drug for cancer patients that shows it can be done.

FDA Decision Signals New Competition For Some Of The Costliest Drugs

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The FDA has approved the first biosimilar drug in the U.S. Biosimilars are like generics but for more complex drugs that can't be replicated exactly because they're made with living cells. They're used to treat diseases like cancer and rheumatoid arthritis. As Elana Gordon of member station WHYY reports, the drugs could save consumers billions of dollars.

ELANA GORDON, BYLINE: Biosimilars have been on the market in Europe for nearly a decade. They've led to a 20 to 30 percent reduction in some drug prices. But in the U.S., there hasn't even been a legal pathway to approve such drugs, until the Affordable Care Act passed in 2010, which brings us to a meeting this winter at the FDA's headquarters in Silver Spring, Md.


MARK MCCAMISH: It's a pleasure for me to be here today to represent the Novartis group of companies.

GORDON: Mark McCamish and his colleagues from Novartis trade-off at a podium in front of a large conference hall. They're making their case before a panel of 14 cancer specialists and a group of FDA regulators for why their drug, Zarxio, should be approved for sale in the U.S. It's similar to Amgen's blockbuster drug Neupogen that's used to fight infections in cancer patients. The application represents uncharted territory in the U.S. because it's for a biosimilar. Jay Siegel is chief biotechnology officer at Johnson and Johnson.

JAY SIEGEL: This is something that we've been waiting for and anticipating.

GORDON: Siegel says biosimilars are not exact replicas because biologics - the drug they're trying to copy - tend to be more complicated.

SIEGEL: In a simplistic sense, biologics are typically much larger molecules. They're usually made by living organisms. They may be like, hormones, other types of proteins, sometimes they're cells, they can be antibodies, whereas most drugs are smaller chemical entities that can be synthesized in the laboratory.

GORDON: Biologics make up a small but costly portion of the U.S. drug market. And it's for that reason that Amye Leong, a patient advocate, traveled to the FDA from California.

AMYE LEONG: What's at stake is my ability to get access to affordable medication.

GORDON: Leong has rheumatoid arthritis. She was in a wheelchair for five years. No more, thanks in part to the biologics she's taking. But she says it's important to approve biosimilars because biologics are often out of reach for patients.

LEONG: In my field - in autoimmune inflammatory arthritis - it's at least $1,800 a month. Now, you want to pay rent, you want to pay food, you want to get your child through school, or do you want the drug that's going to hopefully make a difference in your disease and in your life? It should not have to be about that.

GORDON: The hope is that like generics, biosimilars could offer cheaper, just as effective treatment options for patients likely Leong. The FDA knows cost is a huge issue, but its focus is on whether this drug is similar enough to the original one to be given to patients. Novartis's application received a ringing endorsement from this panel and on Friday, the FDA officially approved the drug.

SCOTT WALDMAN: It was actually pretty straightforward.

GORDON: Scott Waldman, from Thomas Jefferson University in Philadelphia, was on the panel. He says this first biosimilar application actually had it easy. Its use in Europe means scientists know a lot more about it. That's an advantage future applications probably won't have.

WALDMAN: I think this is a pretty high bar to set and that other compounds that come through are going to have to leap over this bar.

GORDON: At least four other applications are in the pipeline. For NPR News I'm Elana Gordon.


This story is part of a reporting partnership with NPR, WHYY and Kaiser Health News.

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