FDA Approves Rheumatoid Arthritis Biosimilar -- Update
April 05 2016 - 6:40PM
Dow Jones News
By Maria Armental
U.S. regulators cleared for sale a knockoff version of Johnson
& Johnson's Remicade anti-inflammatory drug, the second entry
in a fledgling U.S. market for lower-cost copies of pricey
biotechnology drugs.
The U.S. Food and Drug Administration said Tuesday it approved
Inflectra, which was developed by Korea's Celltrion Inc. and
licensed to Pfizer Inc., for treatment of rheumatoid arthritis,
inflammatory bowel diseases and other conditions.
Inflectra is what regulators and the drug industry call a
"biosimilar" to J&J's Remicade, which has been available since
1998 and had U.S. sales of $4.45 billion last year. A biosimilar is
a close copy of a biotech drug, which is usually manufactured in
living cells rather than synthesized chemically like traditional
pills.
The FDA last year approved the first biosimilar -- a Novartis AG
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
the FDA is considering additional biosimilar applications,
including those for some of the biggest-selling biotech brands.
But the road to market for U.S. biosimilars hasn't been smooth
and may not generate the degree of cost savings that some expected.
J&J and other makers of brand-name biotech drugs have sought to
block biosimilars from the market by asserting patent rights for
their drugs. The Neupogen biosimilar from Novartis didn't become
available until about six months after FDA approval -- following
legal wrangling between Amgen and Novartis -- and at just a 15%
discount to the brand price.
It isn't clear when Inflectra will hit the market. J&J sued
Celltrion in federal court in Massachusetts last year, alleging the
Celltrion drug would infringe 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. Celltrion
denied the infringement allegations.
Pfizer, which holds the U.S. marketing rights to the Celltrion
biosimilar, said Tuesday it is "continuing with the preparation of
our launch plans for 2016." But the company said the timing will
depend upon "marketplace dynamics and intellectual property
considerations."
J&J said Tuesday Inflectra is "not identical" to Remicade,
and that the FDA didn't approve Inflectra to be interchangeable
with Remicade.
A Celltrion spokeswoman referred questions to Pfizer.
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.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
April 05, 2016 18:25 ET (22:25 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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