| WASHINGTON, April 26
WASHINGTON, April 26 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 did not give the industry more guidance,
calling the law's technical provisions ambiguous.
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 inside living
cells and cannot be copied exactly to make generic versions.
Insurers expect biosimilars 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. 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.
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, saying the Federal
Circuit 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.
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
(Reporting by Andrew Chung; Editing by Will Dunham)