By Peter Loftus
A U.S. regulatory panel vote on Tuesday is a win for companies
developing lower-cost copies of pricey biotechnology drugs, but it
could be a while before patients see some of them.
An advisory panel to the U.S. Food and Drug Administration voted
to recommend the agency approve the sale of a knockoff version of
Johnson & Johnson's arthritis drug Remicade, which had U.S.
sales of $4.45 billion last year. The copy was developed by
Celltrion Inc. and licensed to Pfizer Inc.
But the path to market for copies of Remicade and other
top-selling biotech brands could be complicated. Drugmakers
including J&J, AbbVie Inc. and Amgen Inc. are attempting to
block such copies, known as "biosimilars," by taking out new U.S.
patents to extend their monopolies potentially into the 2020s and
'30s.
That could delay the entry of competing knockoffs well beyond
when the FDA clears them for sale, and beyond the expirations of
the branded drugs' original patents, which are due in coming months
and years.
Many of the newer patents cover drug-manufacturing processes and
methods of using the drug to treat certain diseases, rather than
the composition of the drug itself, which is covered by the
original patents.
AbbVie, which is facing a looming threat of competition for the
arthritis treatment Humira, said it has taken out about 70 patents
for the drug, one of the largest patent portfolios ever assembled
for a single drug. The drug's primary U.S. patent is due to expire
in December, but AbbVie says the additional patents should keep
copycat versions of Humira off the U.S. market until at least 2022,
and possibly longer.
Most of the later-expiring Humira patents were issued by the
U.S. Patent and Trademark Office in the past two to three years,
more than a decade after the drug was originally approved for sale
in the U.S. in late 2002. AbbVie Chief Executive Richard Gonzalez
told analysts on a conference call in late January the patents are
based on AbbVie's innovation in developing Humira, and that the
company plans to defend them.
An AbbVie spokesman said the patents represent work by AbbVie
scientists dating to the late 1990s, which "continues to
evolve."
The aggressive patent effort reflects the hefty sales and
profits at stake for the manufacturers of biotech brands, and could
pose a "big barrier" to biosimilars, said Chris Raymond, a biotech
analyst with Raymond James. Humira, the highest-selling
prescription drug in the world, generated $14 billion in global
sales last year, more than 60% of AbbVie's total revenue.
The volume of patents also reflects the complex nature of
biotech drugs, which are typically manufactured in living organisms
rather than through the chemical synthesis used for regular pills.
"It's just a lot more complicated to make a biologic. That leads to
more patents," said Zachary Silbersher, a patent attorney with
Markman Advisors, which provides intellectual-property analysis to
investors.
The FDA last year approved the first biosimilar--a version of
Amgen's Neupogen drug for cancer chemotherapy patients--using new
criteria arising from a provision of the 2010 Affordable Care Act
aimed at supporting a biosimilar market. Now it is considering
additional biosimilar applications, including those for some of the
biggest-selling biotech brands.
The FDA panel's vote Tuesday in favor of a biosimilar Remicade
bodes well for future biosimilars because it could signal the FDA
will use looser criteria for marketing approval than some people
expected, analysts say. The panel recommended by a vote of 21-3
that the Celltrion product be approved to treat all of the diseases
that brand-name Remicade is approved to treat, even though the
safety and efficacy of Celltrion's product was tested only in
patients with two of the diseases.
The FDA isn't required to follow the votes of its advisory
panels, but it often does. A final decision on Celltrion's product
is expected later this year.
But even if the FDA approves the Celltrion biosimilar, it is
unclear how soon it could reach the market. Although J&J hasn't
secured as many patents for Remicade as AbbVie has for Humira, it
has secured a number of additional Remicade patents that could tie
up competitors. A J&J spokesman said the company has a number
of patents related to Remicade and "we will continue to defend
intellectual property" for the drug. At Tuesday's FDA panel
meeting, a J&J official urged the agency not to approve
Celltrion's product to treat inflammatory-bowel diseases until
results of studies comparing it with Remicade in patients are
available.
J&J sued Celltrion in federal court in Massachusetts last
year, alleging the Celltrion drug would infringe upon six patents
for Remicade, including one that was issued in 2009 and expires in
2027. The patent covering the drug's composition is due to expire
in 2018. Remicade first hit the U.S. market in 1998. Celltrion
denied the infringement allegations.
Pfizer, which holds the U.S. marketing rights to the Celltrion
biosimilar, said last week it was moving ahead with plans to begin
selling the product this year.
Amgen's Enbrel, an anti-inflammatory drug that competes with
Remicade and Humira, was approved for sale in the U.S. in 1998.
Originally, it appeared that a patent expiration in 2012 could
clear the way for biosimilar competition. But in 2011, Amgen
obtained a new patent for Enbrel that expires in 2028, which could
complicate matters for competing biosimilars. U.S. sales of Enbrel
were $5.1 billion last year.
Novartis AG has applied for FDA approval of a biosimilar,
Enbrel. An Amgen spokeswoman said the company holds patents on
Enbrel that it "may have to enforce against biosimilars." The
company doesn't envision biosimilar competition for Enbrel in the
U.S. "for the foreseeable future."
The patent blitz has forced developers of biosimilars to beef up
their own intellectual-property capabilities. "I have someone in my
office who's tracking 250 different patents or patent applications
for Humira," Denny Lanfear, chief executive of biosimilar developer
Coherus BioSciences Inc., said at an investor conference in
January.
Coherus plans to file an application this year to market a
biosimilar version of Humira, he said. The company says it has
"seen numerous late-filed patents that appear to have no other
purpose than delaying the market entry of biosimilars."
The patent litigation surrounding biosimilars is likely to be
costly and complicated. If the typical generic-drug litigation
battle revolves around half a dozen patents or fewer, court
disputes over biosimilars could involve 20 to 30 patents, says
Elaine Blais, an intellectual property litigator at Goodwin Procter
in Boston. Litigation costs, meanwhile, can be double or more for
biosimilars, compared with traditional generics, Goodwin Procter
lawyers say.
Jeanne Whalen contributed to this article.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
February 09, 2016 18:01 ET (23:01 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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