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FDA Approves Zarxio, First Biosimilar Drug

The approval paves the way for alternatives to an entire class of complex and costly drugs to go on the market. Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products, but until now biosimilar drugs have been insulated from the competition of cheaper copies. The FDA has now finally approved the first biosimilar for use on the American market.

A quite significant decision as it opens the door to a new class of potentially cheaper drugs made using living cells and not synthesized from chemicals like typical drugs.The drug, called Zarxio, produced by Sandoz, is used to help prevent infections in cancerpatients receiving chemotherapy. It is a close copy of an existing medication called Neupogen, made by Amgen. It was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because no regulatory pathway existed to bring biosimilars — approximate copies of drugs in a class known as biologics — to market.

But in January an expert panel unanimously recommended that the F.D.A. approve it, and the agency on Friday announced that it had taken the panel’s advice.

“Biosimilars will provide access to important therapies for patients who need them,” Dr. Margaret A. Hamburg, the commissioner of the F.D.A., said in a statement.

The approval is significant because it opens the door to a new class of potentially cheaper lifesaving drugs for millions of Americans. It involves biologic drugs, which are made using living cells and not synthesized from chemicals like typical drugs. Some popular biologic drugs are Remicadeand Enbrel for autoimmune diseases, and Herceptin and Avastin forcancer. Some of the world’s most expensive medications are biologics.

Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products. But until now, biologics have been largely insulated from the competition of cheaper copies.

“This is the first approval for low-cost alternatives to biological drugs,” Ronny Gal, a senior research analyst who focuses on specialtypharmaceuticals at Sanford C. Bernstein & Company, said in an email. “It will reasonably allow for reduction of cost in older cancer care drugs, clearing room in the budgets for new breakthrough cancer agents.”

Biologic drugs were first developed in the 1980s and were considered so specialized that making generic versions was seen as most likely impossible. But science has advanced, and as patents began to expire, drug companies started developing close copies and seeking F.D.A. approval for them. Companies with the original patents initially resisted, arguing that their drugs were so complex that it was not possible to make a copy, but that position eventually became untenable.

“The F.D.A. approval of Zarxio marks a significant milestone for the United States health care system,” said Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz, which is a division of Novartis.

Analysts said the approval would potentially usher in greater competition and lower prices for this critical class of drugs. “The biological products tend to be products that have very high prices,” Dr. John K. Jenkins, director of the Office of New Drugs in F.D.A.’s Center for Drug Evaluation and Research, said on a call with reporters. “With competition, one of the goals is to see hopefully lower prices to make access better for the patients who need these products.”

Biosimilars are about a third cheaper than brand-name biologic drugs, on average, in countries where they are in use, according to Express Scripts, the nation’s largest manager of prescription drug benefits. Some experts say the discounts could be much steeper, up to 90 percent.

Express Scripts estimates that Zarxio’s introduction in the United States could save $5.7 billion in drug costs over the next 10 years. It estimated that $250 billion in drug costs could be saved over the next decade if 11 biosimilars in development were approved.

A spokeswoman for Novartis, Elizabeth Power, declined to comment on Zarxio’s price.

Amgen, the maker of Neupogen, has gone to court trying to block the sale of Zarxio. It says Sandoz did not follow the rules in terms of informing Amgen in advance of its plans for the drug. Sandoz has denied that. A hearing is scheduled for March 13 on Amgen’s request for a preliminary injunction. Sandoz said it would not start selling Zarxio until a decision was made on the injunction or April 10, whichever came first.

The F.D.A. approved Zarxio for all the uses of its predecessor, Neupogen, and allowed the drug to carry nearly identical language on its label. That suggests that biosimilars as a share of the market may grow quickly, said Mr. Gal, the pharmaceuticals analyst, as they will be allowed to be used as broadly as the drugs they imitate.

“We did not see any differences that would suggest that there would be any situations where a prescriber would have to choose one or the other based on safety and efficacy,” Dr. Jenkins said. “They should perform the same.”

There could be challenges to such use, however. Manufacturers of typical generic drugs do not market their products but instead rely on pharmacists to substitute the generic for a brand-name drug. But such automatic substitution cannot yet happen with biosimilars.

So makers of biosimilars might have to call on doctors to prescribe their drug and persuade insurers to require use of the less expensive biosimilar.

There is also competition. Teva already sells a copy of Neupogen, though that drug, called Granix, was approved through a different process, as a novel drug rather than a biosimilar.

Also, Amgen sells a longer-lasting version of Neupogen, called Neulasta, that requires fewer injections and might be preferred by patients and doctors, even if it is more expensive. Biosimilar versions of Neulasta might also be approved in the next year or two, however.

The agency’s action on Friday also provided clues to its thinking on one hotly debated biosimilars topic: how to name them.

Some generic drug companies and insurers want the biosimilars to have the same generic name as the branded product, so that it will be easier for doctors to use them as substitutes. But some makers of biologics say names should be different to make it easier to trace a drug’s side effects to its manufacturer.

The F.D.A. picked a middle course of sorts but one that left Sandoz and some other makers of biosimilars unhappy. Instead of simply calling Zarxio filgrastim, the generic name for Neupogen, it called the drug filgrastim-sndz, the suffix standing for Sandoz, the manufacturer. Dr. Jenkins said the naming of this particular drug did not necessarily establish a general policy for naming biosimilars.

“The big debate has been ‘Are biosimilars more genericlike or more brandedlike,’ ” Mr. Gal said. “This threads the needle.”

F.D.A. officials said that the agency could disclose requests for drug approvals only if companies had made them public and that four such publicly disclosed requests for approvals of biosimilars were currently in the pipeline. An agency advisory committee was scheduled to meet this month to consider a biosimilar version of Johnson & Johnson’s Remicadebut the meeting was postponed.

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