By Peter Loftus
Generic-drug makers have begun selling lower-priced copies of
the blockbuster anti-inflammatory drug Remicade throughout Europe
in recent days, a milestone in the emerging market for so-called
"biosimilars," or generic versions of complex biotechnology
drugs.
An approaching wave of biosimilars in Europe and the U.S. could
help contain drug spending, while eroding sales of expensive
branded drugs such as Remicade, which is marketed by Merck &
Co. and Johnson & Johnson. Remicade had global sales of $9
billion last year, making it one of the top-selling drugs in the
world.
Hospira Inc., of Lake Forest, Ill., began selling its biosimilar
version of Remicade in the U.K. and Belgium on Wednesday following
patent expirations in those countries, and last week launched in 10
other European countries including Germany and France, a
spokeswoman said.
Hospira's product, Inflectra, will be priced at about 20% to 30%
below the price for branded Remicade, the spokeswoman said. Prices
for Remicade vary by country and use. In the U.K., the drug costs
about GBP420, or $650, per vial, which translates into GBP5,035, or
$7,816, for a starting round of therapy for an average patient with
ulcerative colitis, according to the U.K. National Institute for
Health and Care Excellence.
South Korea's Celltrion Healthcare announced Tuesday it began
selling a biosimilar version of Remicade, which it calls Remsima,
in 12 European countries including the U.K., France and
Germany.
Remicade was one of the earliest of a complex category of
biotechnology drugs when it was introduced in 1998, and is now
approved to treat a range of conditions including rheumatoid
arthritis and gastrointestinal disorders. The drug is infused
intravenously.
Hospira began selling its biosimilar of Remicade in smaller
markets in eastern and central Europe in 2013 and 2014, after
patent expirations there. The European Commission approved Remsima
and Inflectra for sale in 2013. They both contain the same active
ingredient as Remicade, which is also known by the generic name
infliximab, and clinical studies showed their safety, efficacy and
quality to be comparable to Remicade's, according to the European
Medicines Agency.
Merck, which markets Remicade in Europe, reported a 10% decline
in fourth-quarter Remicade sales due to the availability of
biosimilars in some of the smaller European countries. The company
has cautioned that the wave of patent expirations for Remicade this
month in bigger European countries would trigger a more substantial
decline in sales of the brand.
"While we believe we will retain many current patients being
treated with Remicade, we will face increased competition for new
patients and there will be mandatory price reductions in certain
markets," a Merck spokeswoman said Wednesday.
Plans are proceeding to bring biosimilar versions of Remicade to
the U.S. Celltrion last year applied for Food and Drug
Administration approval to market Remsima, which Hospira would
market in a partnership deal between the companies; an FDA decision
is pending. An FDA advisory committee had been scheduled to meet
March 17 to review the proposed product, but the FDA said Wednesday
it was postponing the meeting because it had requested more
information from Celltrion.
The U.S. Patent and Trademark Office this month rejected the
validity of a Remicade patent due to expire in 2018, which could
clear the way for a biosimilar to enter the market before then.
J&J, which markets Remicade in the U.S., said in a news release
it believes the patent is valid and will pursue appeals of the
decision.
Write to Peter Loftus at peter.loftus@wsj.com
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