[Ip-health] Reuters: U.S. Supreme Court speeds copycat biologic drugs to market

Thiru Balasubramaniam thiru at keionline.org
Mon Jun 12 13:29:47 PDT 2017


Mon Jun 12, 2017 | 11:25pm IST

U.S. Supreme Court speeds copycat biologic drugs to market

By Andrew Chung | WASHINGTON

The U.S. Supreme Court on Monday cut the time it will take for copycat
versions of biologic drugs to get to the market in a pivotal ruling about
an expensive class of medicines that can yield billions of dollars in sales
for drug companies.

The justices, in a 9-0 ruling, overturned a lower court's decision that had
prevented Swiss pharmaceutical company Novartis AG from selling its copycat
version of California-based Amgen Inc's Neupogen until six months after the
U.S. Food and Drug Administration approved it.

The decision has major implications for the pharmaceutical industry because
it will dictate how long brand-name makers of biologic drugs can keep
near-copies, called biosimilars, off the market. Even the six months at
issue in the case can mean hundreds of millions of dollars in sales.

Health insurers expect biosimilars to be cheaper than original brands, like
generics, saving consumers billions of dollars each year.

Novartis said in a statement that the ruling "will help expedite patient
access to life-enhancing treatments."

Amgen spokeswoman Kelley Davenport said the company was disappointed but
"will continue to seek to enforce our intellectual property against those
parties that infringe upon our rights."

The dispute involved a section of the 2010 Affordable Care Act, dubbed
Obamacare, that created an expedited path for regulatory approval of
biosimilars while trying to respect the patent rights of brand-name

Novartis complained that the 2015 ruling by the U.S. Court of Appeals for
the Federal Circuit in Washington handed Amgen an extra six months of
exclusivity on top of the 12 years already provided under the law.

Rising drug prices are a matter of concern for patients and policymakers.
President Donald Trump has criticized the pharmaceutical industry over
pricing practices, promising to encourage competition and bring down drug


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.

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

After launch, Zarxio cost 15 percent less than Neupogen at list prices,
according to Novartis. Sales of Neupogen, meanwhile, dropped from more than
$1 billion in 2015 to $765 million last year, primarily due to competition
in the United States, the company said in regulatory filings.

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

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 appeals court ruled that the 180-day notice must be given
after FDA approval, a ruling the Supreme Court reversed on Monday.

Writing for the court, Justice Clarence Thomas said that the decision was
not based on policy arguments, but rather, the "plain language" of the
biosimilar law itself.

The Trump administration had backed Novartis' arguments in the case.

(Reporting by Andrew Chung; Editing by Will Dunham)

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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