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"We were in Los Angeles about to finish our album when Elton John comes out of (a recording studio). "He says, 'hello girls' and kisses us on the cheek and wishes us good luck with our recording. We just had to shake our heads and wonder 'how in the world did that just happen'? <a href=http://www.toryburch.us.org/>www.toryburch.us.org</a> WASHINGTON Federal regulators on Friday approved the sale of the first-ever biosimilar drug in the United States, opening the door to a cheaper class of drugs that could expand patient access to life-saving treatments.The Food and Drug Administration (FDA) approved Novartis AG's copycat version of Neupogen, a biologic cancer drug that recorded $1.2 billion in worldwide sales last year. Novartis already sells biosimilar versions of the drug in more than 40 countries, but Friday's announcement will allow the company to start selling the drug in the United States.Biologics are more complex than traditional drugs made from synthetic chemicals. They're made from living organisms, so they can't be exactly replicated by another product. Instead, the biosimilar manufacturer has to prove that its copycat product is similar enough in safety and effectiveness.Biosimilar manufacturers aren't expected to provide the same level of discounts as traditional generic drugs since these copycat biologic products are much harder to make. For almost a decade, biosimilars have been available in overseas markets, where they usually sell for 20 percent to 30 percent less than the original product. That's much less than the average 75 percent savings that traditional generics provide in the United States.Still, that means biosimilars can save patients thousands of dollars on drugs treating complex diseases, such as cancer and rheumatoid arthritis. The average price of Neupogen was nearly $3,500 for a 30-day supply, according to the pharmacy benefits manger Express Scripts. The company projects that biosimilar competition for Neupogen will mean $5.7 billion in savings to the U.S. health-care system over the next decade, assuming a 30 percent discount from the brand-name price.Sandoz, the Novartis division that manufactures the Neupogen biosimilar, said it won't comment on price until the product's launch. "What we can say is that it will be competitively priced," said Novartis spokeswoman Julie Maslow.Neupogen, a white blood cell booster manufactured by Amgen, is primarily used to help chemotherapy patients fight off infection. The Sandoz version, which will be known as Zarxio in the United States, was approved for the same five uses as Neupogen.FDA officials on Friday assured patients and health-care providers that the new class of biosimilars are up to the standards of the original, or reference, biologic. "There are no clinically meaningful differences" between Neupogen and Zarxio, said John Jenkins, director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research. "Physicians and patients should be confident that Zarxio should behave the same in patients from a safety and efficacy standpoint as Neupogen."Biosimilars have been slow to reach the United States because a regulatory pathway for their approval didn't exist until the 2010 Affordable Care Act. At least four more biosimilar applications are awaiting FDA review.The FDA approval Friday comes a month after the Obama administration expressed "deep concern" about the growing cost of specialty drugs. Health-care payers, who have been sounding the alarm of growing drug costs over the past year, have hailed the introduction of biosimilars as a revolutionary development that will save money and lives. The new class of drugs could save the system nearly $45 billion through 2024, according to a Rand Corporation analysis.Page 2 of 2 - The actual savings, though, could depend on regulatory decisions the FDA must still make. That includes whether biosimilars should share the generic name of the drug that they're copying, which would help make the copycat products more prevalent.For instance, the generic name for Neupogen is filgrastim, based on its active ingredient. For now, Zarxio will carry the generic name "filgrastim-sndz." However, the FDA said it will soon offer official guidance on naming.The FDA is also expected to issue more guidance on "interchangeability," which could mean greater takeup of biosimilars. A product deemed interchangeable could be automatically substituted for the original biologic at the pharmacy, similar to how traditional generics replace their brand-name counterparts.
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