[Ip-health] Reuters: U.S. top court grapples over making copycat biologics available sooner

Thiru Balasubramaniam thiru at keionline.org
Wed Apr 26 14:04:37 PDT 2017


HEALTH NEWS | Wed Apr 26, 2017 | 2:21pm EDT

U.S. top court grapples over making copycat biologics available sooner

By Andrew Chung | WASHINGTON

U.S. Supreme Court justices on Wednesday struggled over whether to speed up
the time it takes to bring to the market copycat versions of biologic
drugs, expensive medicines that can generate billions of dollars in sales
for drug makers.

The nine justices heard arguments in an appeal by Novartis AG of a lower
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

The ruling in the case, due by the end of June, could determine how quickly
patients have access to near-copies of biologic drugs called biosimilars at
potentially cheaper prices.

The case involved a section of the 2010 Affordable Care Act, dubbed
Obamacare, that created an expedited path for regulatory approval of
biosimilar drugs.

The justices tried to make sense of the complex law and how Congress
intended to balance the patent rights of brand-name manufacturers and the
ability of biosimilar drug makers to bring copycat products to the market.

Justice Stephen Breyer expressed frustration, wondering why federal
regulators had not given the industry more guidance.

"We are being asked to interpret very technical provisions that I find
somewhat ambiguous and am operating in a field I know nothing about,"
Breyer said. "But it's going to have huge implications for the future."

Novartis complained that the lower court ruling favoring Amgen gave the
brand-name manufacturer an extra six months of exclusivity on top of the 12
years already provided under federal law.

The justices gave little indication as to how they would rule, although
Justice Sonia Sotomayor suggested to Amgen's attorney Seth Waxman she did
not share his assumption that biosimilars may only be launched six months
after the 12-year mark.

"You only have an exclusive license for 12 years," Sotomayor said.


Rising drug prices are a matter of concern for patients and policymakers.
President Donald Trump has said he is developing a plan to encourage
competition in the pharmaceutical industry and bring down drug prices.

Unlike traditional drugs, biologics are made from living cells and cannot
be copied exactly to make generic versions. They are used to treat a range
of conditions, including Crohn's disease, ulcerative colitis, rheumatoid
arthritis, plaque psoriasis, breast cancer and diabetes.

Health insurers expect biosimilars to be cheaper than original brands, like

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

After launch, Zarxio cost 15 percent less than Neupogen at list prices,
according to Novartis.

Biologics account for an ever-increasing share of U.S. prescription drug
costs, according to legal papers filed by an insurer trade group supporting
Novartis. It cited as an example AbbVie Inc's Humira, which costs more than
$50,000 per year.

Amgen sued Sandoz in 2014 in San Francisco federal court alleging patent
infringement and violations of the Affordable Care Act provision governing
biosimilars. The companies disagreed on how to apply that 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 appealed to the Supreme Court.

(Reporting by Andrew Chung; Editing by Will Dunham)

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