Supreme Court urged to weigh in on six-month biosimilar delays

Amgen's Neupogen is at the center of a legal battle that could affect the introduction of all biosimilar drugs.

Novartis’ Sandoz unit has been marketing Zarxio, its biosimilar version of Amgen’s blockbuster drug Neupogen, for more than a year, but the drug is still tangled in a patent fight that boils down to one central question: Should biosimilar makers have to give six months' notice to the original drugmaker after they receive FDA approval for their copycat version? The answer will affect not only Novartis and Amgen, but any company seeking to make a biosimilar product.

Now the onus is on the U.S. Supreme Court to answer that question. The U.S. Solicitor General, Ian Heath Gershengorn, this week asked the Supreme Court to interpret the 2009 law that originally laid out the proper procedure for seeking FDA approval for biosimilar drugs. The proper interpretation of the law, he wrote in a brief, will have a “significant impact” on the biotech companies that hope to “promptly to bring their biosimilars to the public,” according to a blog post by the Regulatory Affairs Professionals Society.

The issue first came to the Supreme Court back in June, after Amgen won an appeals court case in which it claimed Sandoz improperly gave 180-days notice before the FDA approval of Zarxio instead of after it. The Court requested that the Solicitor General file a brief “expressing the views of the United States.”

In that case, Amgen argued that the extra six months was essential to giving drugmakers another chance to examine patents and raise infringement issues. But Gershengorn has a problem with that reasoning, he wrote in this week’s filing, because “the owner of a biosimilar with an effective license could be forced to wait 180 days after FDA has authorized it to commence marketing, even if the sponsor had no arguably valid infringement claim to warrant such delay.”

Six months may not sound like a long delay, but when you consider the premiums charged for biotech drugs, it’s pretty clear why companies like Amgen want to hold onto their blockbusters as long as possible. Neupogen, originally approved in 1991 to treat neutropenia in cancer patients, brought in sales of nearly $1.2 billion in 2014, but biosimilar competition pushed sales down 9% last year. Sales in the third quarter of this year plummeted 36% to $183 million.

The Supreme Court’s decision could affect another Amgen patent battle, too, this one with Apotex, which is developing a biosimilar version of Neulasta, the second-generation version of Neupogen. Apotex tried to side-step the six-month notice period, but Amgen prevailed. The ruling is now under appeal. Last month, Amgen field a brief in that case arguing that Apotex’s appeal was redundant in light of the Sandoz case, according to a blog post from the law firm Goodwin. Amgen called the Sandoz case the “elephant in the room”—an apt cliché considering its potential impact on the entire biotech industry.