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Biosimilars Hit the Market

Novartis opens the flood gates

Novartis has said that it would begin selling the first biosimilar drug in the U.S. at a 15% discount to the original after an appeals court denied Amgen’s request to block the Swiss drug maker’s sale of its copycat version of blockbuster remedy Neupogen, according to a report in the Wall Street Journal.

Novartis’ move followed a decision on September 2 by the U.S. Court of Appeals for the Federal Circuit that cleared the way for the firm’s Sandoz unit to start selling Zarxio (filgrastim) , a knockoff version of Neupogen that was approved by the FDA in March. The drugs help to boost the white-blood-cell count in chemotherapy patients and others with compromised immune systems.

The drug industry and its lawyers have been closely watching the Neupogen biosimilar case because the outcome could shape the path to market for a coming wave of biosimilar drugs that are expected to cost less than the original brands.

Unlike generic drugs, which copy “classic” chemically made drugs, biosimilars mimic biotechnology agents made through more complex processes involving living cells. The results are a close, but not exact, copy.

The U.S. market accounted for more than 70% of Amgen’s $1.16 billion in global sales of Neupogen last year.

A Novartis spokesman said the company would sell Zarxio at a 15% discount to Neupogen, based on list prices. For example, a 300-mcg syringe of Zarxio would list for $275.77, compared with $324.30 for an equivalent dose of Neupogen. The pricing is on the low end of the 15% to 30% discounts on biosimilars in Europe, where they have been available for several years. But the Novartis spokesman said he expected a “similar competitive dynamic to play out in the U.S.” as in Europe, where the discount for its biosimilar Neupogen has increased to 20% to 30% as more participants have entered the market.

More biosimilar versions of Neupogen are expected to launch in the U.S. Apotex Inc., a Canadian generic-drug manufacturer, has applied for FDA approval to market its version of Neupogen, a product jointly developed with Intas Pharmaceuticals Ltd. of India. An Apotex spokesman said the application is under review.

Zarxio was the first biosimilar approved by the FDA under abbreviated criteria enabled by a provision of the Patient Protection and Affordable Care Act. However, the product’s introduction was delayed by a legal dispute between Amgen and Novartis.

The dispute began when Amgen filed a lawsuit in federal court in San Francisco last year, accusing Novartis of failing to disclose certain information about its copycat product to Amgen, which the U.S. firm said was required under the new criteria for FDA approval of biosimilars. Amgen also alleged that Zarxio would infringe on a patent for Neupogen. Novartis denied the allegations.

Source: Wall Street Journal; September 3, 2015

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