Photographer: Dario Pignatelli/Bloomberg

Amgen Fight Over Copies of Biotech Drugs Gets High Court Review

The U.S. Supreme Court agreed to hear a dispute that could help clarify the steps needed to get low-cost alternatives to pricey biotechnology drugs on the market.

It will be the first time the high court has agreed to interpret a 2010 provision of Obamacare that enabled the U.S. Food and Drug Administration to approve biosimilars, which are copies of medicines based on living organisms. The law created a complex set of steps known as a “patent dance” that courts and regulators have struggled to interpret.

The case centers on an application by Novartis AG’s Sandoz unit to sell a copy of Amgen Inc.’s Neupogen, a white blood cell booster that’s been on the market since 1991. Sandoz began selling Zarxio, the first biosimilar of any drug in the U.S., in September 2015. Zarxio was approved for use in Europe in 2009.

Both Amgen and Sandoz challenged portions of a fractured decision by the U.S. Court of Appeals for the Federal Circuit that set the September approval date.

The Federal Circuit, which handles all patent appeals, said Sandoz wasn’t required to give Amgen information about its biosimilar application, including a description of the proposed manufacturing process. The court said Amgen could instead file a patent-infringement suit and seek to halt sales through that route. The company’s suit is scheduled for trial in December in San Francisco.

Amgen argued the law said Sandoz “shall’’ give the information, and a violation of that merited an order preventing sales of the product.

Sandoz challenged a portion of the decision that said Sandoz had to give Amgen 180 days’ notice after getting FDA approval before it could begin sales.

The U.S. solicitor general recommended the court take both cases, saying they address “core questions governing how” the biosimilars act will work.

While Sandoz was the first to get FDA approval to sell a biosimilar, other companies are in the wings. Even Amgen is embroiled in a fight to sell a biosimilar of AbbVie Inc.’s rheumatoid arthritis treatment Humira, the world’s top-selling medicine with $11.8 billion in sales during the first nine months of 2016.

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.

Generics and biosimilars are both meant to be lower-cost alternatives to expensive branded medicines, though it’s much more difficult to develop a copy of a biotech drug and test it to make sure it has the same effect on patients.

The biosimilars law was designed to clear the path for lower-cost versions to enter the market while ensuring that creators of biotech drugs get compensation for the years they spend in development and regulatory review. Those competing aims left it up to the courts to “do our best to unravel the riddle, solve the mystery and comprehend the enigma,” Federal Circuit Judge Alan Lourie wrote in his majority opinion.

Mylan NV and Pfizer Inc.’s Hospira were among those backing Sandoz’s appeal.

“Given the importance of the issue to consumers, taxpayers and competition in a vital new pharmaceutical industry, review is needed now,” Hospira and Celltrion Inc. said in a filing with the court.

The cases are Sandoz v. Amgen, 15-1039, and Amgen v. Sandoz, 15-1195.

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