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 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 it.
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.
PATIENTS AND POLICYMAKERS
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.
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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 generics.
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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