Landmark Ruling: Amgen Loses Bid to Delay Biosimilars

Landmark Ruling: Amgen Loses Bid to Delay Biosimilars June 13, 2017
By Alex Keown, Breaking News Staff

WASHINGTON – The road to market biosimilars in the United States just got a little easier. On Monday, the U.S. Supreme Court unanimously ruled that biosimilar drugmakers do not have to wait an extra six months following regulatory approval to market their products.

The court made its announcement when deciding the lawsuit between generic drugmaker Sandoz and California-based Amgen . The Supreme Court’s decision overturns an earlier ruling by a federal appeals court that sided with Amgen, which had argued in favor of the additional 180 days a biosimilar manufacturer must wait before launching after approval from the U.S. Food and Drug Administration. Now biosimilar manufacturers can get into the U.S. market much quicker, which could potentially result in the savings of billions of dollars for U.S. consumers. Amgen had been seeking to delay the launch of Sandoz’ biosimilar to its blockbuster cancer drug Neupogen.

Carol Lynch, the global head of biopharmaceuticals at Sandoz, hailed the ruling as a benefit to patients and the healthcare industry. She said the company, as a leader in biosimilar manufacturing, has the responsibility to eliminate barriers to high-cost drugs.

“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system. The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” Lynch said in a statement.

Amgen had sought to halt Sandoz’ sales of Zarxio, which was the first biosimilar approved in the United States. Zarxio was approved under the biosimilars pathway established by the Biologics Price Competition and Innovation Act. In July 2015, a U.S. appeals court ruled that Novartis had to wait until Sept. 2 of that year to launch its biosimilar. An Amgen spokesperson told Reuters that the company was disappointed with the ruling, but would continue to protect its intellectual property rights.

In its argument before the high court, Sandoz said biologic drugmakers already have 12 years of market exclusivity and the additional six months granted by the FDA costs manufacturers millions in sales, as well as forced patients to continue paying higher prices. Sandoz’ biosimilar costs about 15 percent less than Amgen’s Neupogen, according to a report in The Hill.

Amgen has been the target of multiple biosimilar drugs. In addition to Neupogen, biosimilar drugmakers have been developing copies of its rheumatoid arthritis drug Enbrel and its anemia drug Epogen. Sandoz is also developing biosimilar version to Amgen’s Neulasta, called pegfilgrastim, which is used to fight infection in cancer patients.

Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010.

Biosimilar drugs are a corner-piece of Novartis’ pipeline. In 2015, Joe Jimenez, Novartis’ chief executive officer, said the biosimilar market will continue to grow. He said at the time he expected biosimilar revenue, which at the time was about $500 million, to grow by 20 percent annually.

Shares of Amgen are down slightly this morning, trading at $164.78. Shares of Novartis, Sandoz’ parent company, are up slightly this morning, trading at $81.50.

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