SAO PAULO, June 2, 2015 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), a global leader in biosimilars, today announced that
its partner, Celltrion – a global biopharmaceutical company –
has received approval from ANVISA – the National Health
Surveillance Agency in Brazil –
for Remsima (infliximab), the first biosimilar monoclonal antibody
approved for use in Brazil. The
medication will be marketed by Hospira. Hospira also markets and
sells biosimilar infliximab in 26 European countries and in
Canada under the brand name
Inflectra. This important product has been approved in Brazil for the treatment of: rheumatoid
arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis,
Crohn's disease in adults and children, fistulizing Crohn's disease
(advanced), colitis and ulcerative rectocolitis.
Remsima is the first biological medication approved by
Brazil's regulator, ANVISA, based
on comparability. A comparability study is required because under
ANVISA's Normative Resolution RDC 55/2010, biosimilarity must be
proven by direct comparison with the reference biological drug
(products must be compared in a single clinical trial and using the
same procedures). The study provided evidence of similarity between
Remsima and the reference biological product,
Remicade™ (infliximab).
"Biosimilars with comparative data of safety and efficacy are
welcome by health professionals and also by the patients who use
them. The effectiveness and safety of medications should be the
foremost concern of those who manufacture, purchase and prescribe
these drugs," said Valderilio Feijo Azevedo, M.D., a rheumatology
specialist of the Brazilian Rheumatology Society and coordinator of
the Brazilian and Latin American Forum for Biosimilars
2010-2014.
In a phase III trial involving 606 patients, Remsima achieved
its main goal of treatment equivalence with Remicade. The trial
showed that 73.4 percent of patients receiving Remsima achieved a
20 percent or better improvement in rheumatoid arthritis symptoms
(based on American College of Rheumatology criteria) after 30 weeks
of treatment, compared with 69.7 percent for Remicade.
During the same trial, 42.3 percent of patients receiving
Remsima achieved a 50 percent or better improvement in rheumatoid
arthritis symptoms (based on American College of Rheumatology
criteria) after 30 weeks of treatment, compared with 40.6 percent
for Remicade. Remsima also presents a similar safety and
tolerance profile to Remicade.
"A robust package of comparative analyses involving Remsima and
Remicade showing biosimilar infliximab's effectiveness and safety
during rheumatoid arthritis treatment, as well as supporting data
for ankylosing spondylitis, allowed us to extrapolate the data and
gain approval from ANVISA to use the biosimilar in treatments for
all approved indications of the reference product, without the need
for additional clinical trials," said Sergio Teixeira, M.D., medical director for
Hospira Brazil.
We are looking forward to offering patients in Brazil better access to high-quality,
effective and more affordable treatment options that can also help
alleviate some of Brazil's rising
healthcare costs," continued Teixeira.
Remsima and Inflectra were approved by the European Medicines
Agency (EMA) in 2013 and are currently available in most European
countries. Celltrion submitted an application to ANVISA to approve
Remsima and Hospira will market the product exclusively in
Brazil.
Hospira and South Korea-based
Celltrion entered into a business cooperation agreement in 2009 for
eight biosimilar products, including biosimilar infliximab. Hospira
and Celltrion recently expanded their biosimilars partnership,
which now provides Hospira with exclusive rights to distribute
biosimilar infliximab in many major markets, including Brazil, Mexico, United
States, as well as in many European countries and in
Canada. Under this agreement, Hospira will assume
responsibility for sales and marketing for this important
medication in Brazil, under the
brand name, Remsima.
With 12 biosimilars in its pipeline, Hospira has one of the
largest biosimilar portfolios in the industry. The company has more
than seven years of experience with biosimilars and has supplied
more than 10 million doses of biosimilar medication to patients
worldwide.
About Remsima
Remsima (infliximab) is a chimeric human-murine monoclonal
antibody that binds with high affinity to both soluble and
transmembrane forms of TNF alpha but not to lymphotoxin α (TNF
beta). Remsima is indicated for: rheumatoid arthritis, adult
Crohn's disease, pediatric Crohn's disease, fistulizing Crohn's
disease, colitis, ulcerative rectocolitis, ankylosing spondylitis,
psoriatic arthritis and psoriasis.
About Hospira
Hospira, Inc. is a global leader in biosimilars and the world's
leading provider of injectable drugs and infusion technologies.
Through its broad, integrated portfolio, Hospira is uniquely
positioned to Advance Wellness™ by improving patient and caregiver
safety while reducing healthcare costs. The company is
headquartered in Lake Forest, Ill.
Learn more at www.hospira.com.br.
About Celltrion
Headquartered in Incheon, Korea, Celltrion is a leading
biopharmaceutical company, specializing in research, development
and manufacture of biosimilar and innovative drugs. Celltrion
strives to provide more affordable biosimilar mAbs to patients who
previously had limited access to advanced therapeutics. Celltrion
previously received EMA approval for Remsima which is the world's
first biosimilar mAb to receive approval from a regulatory agency
in a developed country.
-- A Caution Concerning Forward-Looking Statements --
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements generally relate to future events or Hospira's future
financial or operating performance. In some cases, you can identify
forward-looking statements because they contain words such as
"may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or
the negative of these words or other similar terms or expressions
that concern Hospira's expectations, strategy, plans or intentions.
Forward-looking statements in this press release include the
outcome of naming decisions related to biosimilars, the pace of
growth of the U.S. biosimilars market and the action of
competitors. Hospira's expectations and beliefs regarding these
matters may not materialize, and actual results in future periods
are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various factors, including, without
limitation, challenges inherent in creating and developing
compounds and product candidates and economic, competitive,
governmental, regulatory, legal, supply and other factors.
Information on these and additional risks affecting Hospira's
business and operating results are more fully discussed in the
section entitled "Risk Factors" in the company's most recently
filed annual report on Form 10-K and any subsequently filed
quarterly report on Form 10-Q. The forward-looking statements in
this press release are based on information available as of the
date hereof, and Hospira disclaims any obligation to update any
forward-looking statement, except as required by law.
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SOURCE Hospira, Inc.