[Ip-health] Wall Street Journal: "Panel Recommends FDA Approval of Remicade Knockoff" - "Vote on copy of J&J arthritis drug comes as makers of biotech brands are poised for fierce patent battles"

Thiru Balasubramaniam thiru at keionline.org
Thu Feb 11 09:40:40 PST 2016



Panel Recommends FDA Approval of Remicade Knockoff

Vote on copy of J&J arthritis drug comes as makers of biotech brands are
poised for fierce patent battles

Updated Feb. 10, 2016 9:51 a.m. ET

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 them.

An advisory panel to the 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 top-selling prescription drug in the world by sales, generated
$14 billion in global sales last year, more than 60% of AbbVie’s total

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

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 at wsj.com

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