[Ip-health] WSJ: FDA Panel Backs First ‘Biosimilar’ Drug

Thiru Balasubramaniam thiru at keionline.org
Thu Jan 8 00:52:44 PST 2015


FDA Panel Backs First ‘Biosimilar’ DrugDecision on Novartis Drug Could
Create New Industry of ‘Generic’ Biologic Drugs
Updated Jan. 7, 2015 5:37 p.m. ET

SILVER SPRING, Md.—A U.S. Food and Drug Administration advisory panel on
Wednesday unanimously recommended the agency approve the first “biosimilar”
drug in the U.S., a version of the anti-infective cancer drug Neupogen.

The FDA panel concluded by a vote of 14-0 that a drug called EP2006, which
Novartis  <http://quotes.wsj.com/NOVN.VX>AG ’s Sandoz unit plans to market
in the U.S. under the name Zarxio, is highly similar to Amgen
<http://quotes.wsj.com/AMGN>Inc. ’s Neupogen. Neupogen is designed to
increase white blood-cell counts, and lower infection rates, mostly in
patients getting chemotherapy and other treatments.

The FDA isn’t required to follow the advice of its advisory committees, but
it frequently does. The agency’s larger decision could mark the first in a
wave of lower-cost versions of expensive biologic drugs.

Biologics are complex medications made or extracted from living cells,
blood components and tissue. These drugs—like the rheumatoid arthritis
drugs Remicade and Enbrel, and others—are expected to generate as much as
$200 billion in sales by next year, according to IMS Health

Express Scripts  <http://quotes.wsj.com/ESRX>Inc., the big
prescription-benefit manager, has estimated that the first two biosimilars
likely to get FDA approval, versions of Neupogen and Remicade, could save
$22.7 billion in costs to patients and insurers over their first 10 years.

The Obama administration, through provisions of the 2010 Affordable Care
Act, created a simplified pathway for biosimilars, a path the FDA is

Biosimilars, unlike traditional generics, aren’t precisely identical to the
brand drug. Under the new law, brand-name companies get 12 years to market
their drugs exclusively. The FDA requires that the new versions be “highly
similar” to the original drug, and it is this concept that the agency and
advisory panel evaluated during a daylong Wednesday hearing.

The FDA advisory committee found that the two versions at issue were in
fact clinically very similar. However, some panel members said this
decision may be easier than some decisions in the future about biosimilars.
That is because the Novartis version has been used for years in Europe,
giving reassurance to some panel members.

Committee chairman Dr. Deborah K. Armstrong, oncology professor at the
Johns Hopkins University School of Medicine in Baltimore, said she was
impressed by “fairly robust safety and efficacy data outside the United
States, which makes this decision easier.”

Doctors representing Novartis described the findings of a study of 280
breast-cancer patients randomly assigned to EP2006 or to Neupogen. Patients
had a nearly identical number of days with severe neutropenia, or
abnormally low count of certain white blood cells that fight infection.
There were no serious adverse events judged related to either drug.

Georgetown University oncologist Louis M. Weiner, speaking on behalf of
Novartis, said biosimilars offer great promise, adding that the molecule
has unquestioned clinical value and helps patients.

He and other doctors from both Novartis and the FDA noted that the drug has
already been widely used in other countries, noting that future biosimilars
may not face as easy a path to approval as the Novartis drug. Biosimilars
have often been sold at prices 20% to 30% below brand-name versions.

Various FDA reviewers attested to their view that EP2006 meets the
definition of the law that the biosimilar be “highly similar” to the old
drug in toxicology, safety and effectiveness. The FDA’s Dr. Albert
Deisseroth, a medical team leader at the agency, went a step further,
declaring “there is scientific justification for extrapolating” the
evidence on behalf of EP2006 for all the medical conditions for which
Neupogen has been approved.

The committee recommended that a future approval of the Novartis drug
should in fact be an approval for all existing medical indications for

Another issue still to be resolved by the FDA is whether biosimilars’
names, like their chemistry, should closely mimic the names of their
equivalent brand product, or should be totally distinct.

Novartis’s Sandoz unit said it is pleased with the recommendation and
“proud to lead the way in biosimilars globally.”

Sanford Bernstein & Co. analyst Ronny Gal said that if the drug gets FDA
licensure, Novartis likely will return at some point to ask the FDA to
declare its drug “interchangeable” with Neupogen. This would mean that,
subject to state law, pharmacists could substitute the biosimilar for the
brand version.

Write to Thomas M. Burton at tom.burton at wsj.com

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