U.S. Supreme Court agrees to hear dispute over biologic drug sales

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By Andrew Chung | NEW YORK

NEW YORK The U.S. Supreme Court on Friday agreed
to hear a dispute over whether companies that make copycat
versions of biologic drugs must wait six months after winning
federal approval to begin selling them.

The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the
Swiss pharmaceutical company from selling its biosimilar version
of California-based Amgen Inc’s $1-billion-a-year
Neupogen until six months after the Food and Drug Administration
approved it. The case could determine how quickly patients have
access to biosimilar medicines at potentially cheaper prices.

Unlike traditional drugs, biologic drugs cannot be copied
exactly to make generic versions. A 2010 federal law allows
companies to seek approval to sell near-copies called
biosimilars.

Biologic drugs are complex chemicals made inside living
cells. Insurers expect biosimilars, like generics, to be cheaper
than original brands.

Novartis unit Sandoz in September 2015 began selling Zarxio,
the first biosimilar to win regulatory approval in the United
States. Neupogen and Zarxio boost white blood cell counts in
cancer patients to help fight infections.

Zarxio, which costs 15 percent less than Neupogen at list
prices, has since exceeded $100 million in sales, according to
Novartis.

The dispute arose when Amgen sued Sandoz in 2014 in San
Francisco federal court alleging patent infringement and
violations of the law governing biosimilars. The companies
disagreed on how to apply the law’s requirement that a
biosimilar drug maker give the brand-name manufacturer 180 days
notice before launching its copycat version.

In July 2015, the U.S. Court of Appeals for the Federal
Circuit in Washington ruled that the 180-day notice must be
given after FDA approval.

Novartis last February appealed that decision to the Supreme
Court, saying the Federal Circuit’s ruling improperly gave the
brand-name manufacturer an extra six months of exclusivity on
top of the 12 years already provided for under the law, driving
up healthcare costs.

“If not reversed, (it) will delay access by patients to all
biosimilars for six months longer than Congress intended,”
Novartis said in its petition asking the Supreme Court to take
up the case.

In opposing Novartis’ appeal, Amgen told the Supreme Court
that the statute was meant to foster innovation and clearly
states that the 180-day period cannot begin until the biosimilar
is approved.

The Supreme Court in December declined to hear a similar
case involving Canadian generic drug maker Apotex Inc and Amgen.

The justices on Friday also agreed to resolve Amgen’s appeal
in the same case over whether biosimilar makers must give
brand-name manufacturers a copy of their application to make a
copycat drug after it is submitted to the FDA.

The case is Sandoz v. Amgen in the Supreme Court of the
United States, 15-1039 and Amgen v. Sandoz, 15-1195.



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