FDA approves biosimilar
to J&J's Remicade for multiple diseases
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[April 06, 2016]
(Reuters) - The U.S. Food and Drug
Administration (FDA) on Tuesday approved Inflectra, a cheaper version of
Johnson & Johnson's drug Remicade, to treat Crohn's disease, ulcerative
colitis, rheumatoid arthritis, psoriasis and arthritis of the spine.
Inflectra, made by South Korea's Celltrion Inc in partnership with
Pfizer Inc's Hospira unit, was the second biosimilar approved by the
Celltrion chief executive Kim Hyoung-ki told reporters on Wednesday
that Inflectra is expected to be priced about 20 to 30 percent lower
than Remicade in the U.S. market, but the final price would need to
be decided after discussions with partner Pfizer.
Remicade generated annual worldwide sales of $6.5 billion. Of that,
$4.5 billion were in the United States. Merck & Co sells Remicade in
Europe. Celltrion sells the biosimilar overseas under the brand
Celltrion said in a statement Inflectra gained more than 20 percent
share of the Remicade market in terms of patient numbers in European
countries where the copy is sold as of December 2015. The drug was
approved by European regulators in 2013 and began sales in Europe's
largest countries in February 2015.
A year ago, the FDA approved the first biosimilar - Novartis AG's
Zarxio, which is similar to Amgen Inc's white blood cell-boosting
Remicade and Neupogen are biologic drugs made from living organisms.
Copies of biologic products cannot easily be replicated and are
known as biosimilar, not generic, because they are similar, not
identical, to the original.
Remicade, as well as similar drugs made by AbbVie Inc and Amgen Inc,
work by blocking an inflammation-causing protein called Tumor
Necrosis Factor, or TNF. Dozens of anti-TNF biosimilars are in
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Celltrion said its biosimilar version of Roche's breast cancer
biotech drug Herceptin expects to apply for global approval in the
second half of this year, and its copy of Roche's non-Hodgkin's
lymphoma biotech drug Rituxan, also called MabThera, is currently
awaiting European approval after applying in October.
Shares in Celltrion were down 5.6 percent as of 0353 GMT, compared
to a 0.4 percent gain in the wider market. Analysts said the shares
pulled back after gaining about 20 percent in the run-up to the
widely expected approval after an FDA panel backed Inflectra in
(Reporting by Rosmi Shaji in Bengaluru and Joyce Lee in SEOUL;
Editing by Peter Cooney and Muralikumar Anantharaman)
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