FDA Approves Rheumatoid Arthritis Biosimilar
April 05 2016 - 5:42PM
Dow Jones News
By Maria Armental
U.S. health regulators have approved for sale Pfizer Inc.'s
lower-priced "biosimilar" version of Remicade, a Johnson &
Johnson and Merck & Co. treatment for rheumatoid arthritis.
Inflectra -- which Pfizer Inc. acquired as part of its merger
with Hospira -- is already approved for sale in Canada, Mexico,
Australia and parts of Europe.
It is the second "biosimilar" approved for sale in the U.S.,
following last year's Food and Drug Administration approval of
Novartis AG's Zarxio , a rival version of Amgen Inc.'s
Neupogren.
Biosimilars, derived from living organisms, are approved based
on a showing that they are highly similar to an already approved
biological product and that they have no clinically meaningful
safety and effectiveness differences from the originally approved
product, according to the FDA.
In the U.S., Inflectra will have a boxed warning of higher risk
of serious infections leading to hospitalization or death,
including tuberculosis, bacterial sepsis and invasive fungal
infections, the FDA said.
Inflectra is made by South Korea's Celltrion Inc.
Pfizer's stock, up 2% during regular trading, rose 0.6% to
$31.55 after hours.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
April 05, 2016 17:27 ET (21:27 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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