First biosimilar goes on sale in U.S., challenging Amgen

GENEVA – Novartis AG began selling the first copy of a biotechnology drug in the U.S., offering a 15 percent discount to the original after a U.S. appeals court rejected Amgen Inc.’s last-ditch effort to protect its blockbuster cancer drug Neupogen.

Zarxio will cost $275.66 per 300 microgram syringe, and for $438.98 per 480 microgram syringe, the Swiss drugmaker said in an e-mailed statement. Both prices are 15 percent lower than Neupogen’s, according to Bloomberg Intelligence. Novartis said it will offer further discounts to drug benefits managers.

Zarxio is part of a class of copies called biosimilars that threaten $50 billion in annual sales of drugs made by companies such as Johnson & Johnson and AbbVie Inc., Bloomberg Intelligence estimates. While generics are exact copies of drugs with simple chemical structures, biosimilars replicate more complex compounds made from living organisms, and aren’t called generics because no two batches are exactly the same.

Novartis is also working on biosimilars of AbbVie Inc.’s $12.5 billion-a-year medicine Humira and Amgen’s Enbrel, according to Michael Leuchten, an analyst at Barclays Plc in London.

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The U.S. Food and Drug Administration approved Zarxio in March, but its introduction was delayed after Amgen sued. An appeals court ruled in July that Novartis could start selling its product on Sept. 2, and Amgen’s request for a temporary injunction to block the drug was turned down on Wednesday. While Novartis’s prices match what analysts expected, the company will probably aim to steal market share from Amgen by offering benefit managers further undisclosed rebates, Leuchten said.

The price “will vary by customer based on factors such as usage, volumes, etc.,” Dermot Doherty, a spokesman for Novartis, said in an e-mail. Zarxio’s arrival will also likely “drive further discounts by originators and other competitors.”

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