High court ruling speeds up generic biotech drug approval

High court ruling speeds up generic biotech drug approval

The justices, in a unanimous 9-to-0 vote, overturned a lower-court decision that had prevented Swiss pharma company Novartis from selling its copycat version of California-based Amgen's Neupogen (filgrastim) until six months after the FDA approved it.

Biologic drugs are isolated from living organisms, and they can't be exactly copied for generics.

As it stands right now, biosimilars can't be used interchangeably with branded versions, meaning if you were to get a prescription for a branded biologic, you wouldn't be able to opt for the "generic" one at the pharmacy as easily as you could if the drug was, say, a statin. To develop a biosimilar, it usually takes about eight years and can costs about $250 million.

The extra time can add billions of dollars in additional sales to the original drug makers before biosimilars enter the market. Express Scripts, a pharmacy benefit manager, estimated in 2013 that the U.S. could be saving $250 billion over the next 10 years because of biosimilars.

Monday's decision was nominally about a dispute between Amgen Inc. and Sandoz Inc., but it was mostly about setting rules for the whole biosimilars world.

Filgrastim-sndz is designed primarily to decrease incidence of infection - manifested by febrile neutropenia - among patients with nonmyeloid malignancies who also receive myelosuppressive anticancer drugs. That law requires biosimilar makers to give a six-month notice of sales to rivals.

Bacsinszky, Ostapenko advance to French Open semis
But the duo put on a terrific performance to make the day memorable - not least setting a semi-final on their shared birthday. Ostapenko will aim to give herself the best present she could wish for and spoil Bacsinszky's 28th birthday later this week.

Novartis said in a statement that the ruling "will help expedite patient access to life-enhancing treatments". Sales of Neupogen, meanwhile, dropped from more than $1 billion in 2015 to $765 million a year ago, primarily because of competition in the United States, the company said in regulatory filings.

But the Supreme Court, in an opinion written by Justice Clarence Thomas, found that the law's "plain language" said otherwise.

The case between the two parties arose after Amgen and Sandoz disagreed over the interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval.

Biologics account for an ever-increasing share of USA prescription drug costs, according to an insurer trade group.

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