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(Bloomberg) -- Novartis AG’s imitation of Amgen Inc.’s cancer drug Neupogen won the backing of U.S. advisers, taking a step closer to becoming the first biosimilar drug for sale in the U.S.
Novartis’s biosimilar, which it plans to call Zarxio, should be approved for the same five conditions that Neupogen treats, advisers to the Food and Drug Administration voted today. The treatment seeks to increase cancer patients’ white blood cell counts. The FDA itself, expected to decide whether to approve the biosimilar in March, doesn’t have to follow the advisory panel’s recommendation.
Neupogen, which generated an estimated $1.2 billion in sales for Amgen in 2014, is part of the growing class of biologic medicines that are more complex than chemical drugs. They also are typically more expensive and, unlike chemical drugs, have never faced generic competition before. The U.S. may save $44 billion in drug spending in the next 10 years by introducing biosimilars, according to Rand Corp.
“This has been utilized extensively in other parts of the world,” Deborah Armstrong, chairwoman of the FDA panel and oncology professor at Johns Hopkins University School of Medicine, said during the meeting. “There’s fairly robust safety and efficacy data that makes some of this a little bit easier.”
FDA staff supported approving Zarxio for all five conditions in a report released Jan. 5.
Novartis’s biosimilar version of Neupogen “meets the requirement for a demonstration of ‘no clinically meaningful differences’ between the proposed product and the reference product in terms of safety, purity, and potency,” FDA reviewers said.
The FDA only gained the power to approve a biosimilar in the 2010 Patient Protection and Affordable Care Act, also known as Obamacare. Chemical drugs have faced generic competition for more than three decades. Imitations of biologic drugs are called biosimilars instead of generics because they’re made from living organisms, which can’t be precisely copied.
Novartis, based in Basel, Switzerland, has sold biosimilar Neupogen in Europe, where it uses the brand name Zarzio, since 2009.
Biosimilars aren’t expected to slash drug prices by 80 percent like chemical generics. Economic and actuarial studies included in the Rand report estimated the $44 billion in savings from biosimilars over a decade assumed the imitations would cut prices anywhere from 10 percent to 50 percent.
Novartis may charge the same for Zarxio as Amgen’s Neupogen in some situations, though the cost to insurers and consumers will be lower, Mark McCamish, head of global biopharmaceutical and oncology injectables development at Novartis’s generic unit Sandoz, told the advisory panel.
A big part of that lower cost will come in the form of rebates -- payments pharmaceutical companies make to insurers based on a negotiated discount. Rebates are mandated for government programs like Medicaid.
The FDA isn’t allowed to take the price of drugs into consideration when it decides whether to approve them, making the discussion at the meeting unusual.
The average price Amgen charges wholesalers before rebates and other discounts for Neupogen is $314.80 for a 300-microgram syringe of the the drug, Kelley Davenport, a spokeswoman for Amgen, said in an e-mail. Neupogen also comes in 480-microgram syringes. The amount patients need depends on their weight.
The FDA hasn’t yet decided how drugmakers will prove their biosimilars are interchangeable with the brand-name treatments they imitate and can safely be swapped at the pharmacy counter. The FDA said Jan. 6 that it plans to release four guidance documents this year that relate to biosimilars, including interchangeability.
The agency had approved some imitations of biologic drugs before it established the abbreviated biosimilar pathway, meaning those treatments aren’t considered true biosimilars. One of those was Teva Pharmaceutical Industries Ltd.’s version of Neupogen, which the FDA cleared for sale in 2012 under the name Granix. That drug has grabbed 5 percent to 10 percent of the market share for Neupogen, Michael Yee, an analyst for RBC Capital Markets, said in a Jan. 5 note.
Biosimilars blur the line between what are considered name- brand drugmakers and generic manufacturers. Novartis, which develops medicines like anti-cancer treatment Gleevec, has a generic drug unit, Sandoz, that will make the biosimilar for Neupogen. In addition to introducing drugs like Neupogen, Thousand Oaks, California-based Amgen is working on biosimilars of its own, including an experimental version of AbbVie Inc.’s best-seller, the psoriasis drug Humira.
The FDA has other biosimilars candidates to consider soon. Celltrion Inc., a South Korea-based generic-drug company, filed an application in August for an imitation of Johnson & Johnson’s arthritis treatment Remicade. Apotex Inc. said in December that it filed for FDA approval of a biosimilar version of Amgen’s cancer medicine Neulasta.
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