-- Subsequent entry biologic (SEB) medicine provides a
lower-cost, high-quality, safe and effective therapy for rheumatoid
arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis
(PsA) and plaque psoriasis (Pso) --
MONTREAL, March 30, 2015 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), a global leader in biosimilars and the world's leading
provider of injectable drugs and infusion technologies, announces
the availability of INFLECTRA™ (infliximab) in Canada, the country's first subsequent entry
biologic (SEB) monoclonal antibody (mAb) therapy. Approved by
Health Canada, INFLECTRA is available to healthcare practitioners
for the treatment of patients with rheumatoid arthritis (RA),
ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque
psoriasis.
An SEB (also referred to as a 'biosimilar' outside of
Canada) is a biologic medicine
made from a living organism or cell. SEBs deliver comparable
clinical effects to their reference biologics while providing the
opportunity for cost savings to the Canadian healthcare system.
"By providing subsequent entry biologic therapies, we can offer
patients better access to high-quality, effective treatment
options, and can help alleviate some of Canada's healthcare costs," said Gerry Stefanatos, corporate vice president,
Canada and Australia/New
Zealand, Hospira. "We are very proud to bring INFLECTRA to
Canada -- offering physicians,
clinicians and patients a treatment option that maintains similar
quality, efficacy and safety to its reference product."
In addition, Hospira has developed an in-depth patient
assistance program to help provide infusion-clinic access to
qualifying patients across Canada,
along with numerous other patient services.
"Canada is truly a unique
country in that the majority of infliximab infusions take place
outside of hospitals. Hospira has focused on providing the best
possible experience for patients prescribed INFLECTRA, from the
moment they leave the physician's office to the actual
administration of the product in the infusion clinics," continued
Stefanatos.
INFLECTRA is biosimilar to the reference product
REMICADE® (infliximab), and was the first of its kind to
be approved through the Health Canada SEB regulatory pathway.
REMICADE recorded sales of nearly CAD $800
million in Canada in
2014.1
Hospira has the exclusive distribution rights to INFLECTRA in
several major markets, including Canada. Bringing SEBs to Canada is the next major step towards driving
healthcare cost savings and improving patient access to
high-quality, more affordable biologic drugs. Biologic products,
including SEBs, treat some of the most widespread and
difficult-to-treat illnesses, such as cancer and chronic kidney
diseases, as well as autoimmune diseases.
For an SEB to be approved in Canada, it must show comparative quality,
clinical efficacy and safety to the reference product. SEBs
developed in line with Health Canada's requirements can be
considered a therapeutic alternative to an existing biologic.
Health Canada approved INFLECTRA
following a review of safety, efficacy and tolerability data from a
comprehensive development program. In a phase 3 (randomized,
double-blind) study in rheumatoid arthritis patients, INFLECTRA met
its primary endpoint of biosimilarity to REMICADE. Safety and
tolerability data showed a similar safety profile for INFLECTRA
versus the known safety profile of REMICADE.2
"Hospira is a leader in providing safe, effective, biosimilar
medicines," said Sumant Ramachandra, M.D., Ph.D., senior vice
president and chief scientific officer, Hospira. "After a
rigorous scientific review and approval process, the availability
of this important product paves the way in Canada for patient access to lower-cost
biologic therapies."
Patients and healthcare professionals outside North America have long had access to
biosimilars -- the European Medicines Agency (EMA) approved the
first biosimilar in 2006.3
With one of the largest biosimilar pipelines in the industry,
Hospira has many years of experience in the field of biologics.
INFLECTRA is currently available in 26 countries across
Europe, and during the last seven
years, Hospira has provided more than 10 million doses of SEB
medicines to patients in Europe
and Australia.
About Hospira Canada
Located in Montréal, Quebec,
Hospira Healthcare Corporation is the Canadian headquarters of
Hospira and represents the company's second largest commercial
presence. Hospira Healthcare Corporation markets products integral
to increasing safety and reducing healthcare costs, including
generic injectable drugs, infusion technologies and subsequent
entry biologics (SEBs) or biosimilars -- which are biologic
medicines that offer cost savings. Learn more
at www.hospira.ca.
About Hospira
Hospira, Inc. is the world's leading provider of injectable
drugs and infusion technologies, and a global leader in
biosimilars. 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.
About INFLECTRA
INFLECTRA is indicated for use, in combination with
methotrexate, for the reduction in signs and symptoms, inhibition
of the progression of structural damage and improvement in physical
function in adult patients with moderately to severely active
rheumatoid arthritis. INFLECTRA is indicated for the reduction of
signs and symptoms and improvement in physical function in patients
with active ankylosing spondylitis who have responded inadequately,
or are intolerant to, conventional therapies.
INFLECTRA is indicated for reduction of signs and symptoms,
induction of major clinical response, and inhibition of the
progression of structural damage of active arthritis, and
improvement in physical function in patients with psoriatic
arthritis.
Important Safety Information
INFLECTRA is indicated for the treatment of adult patients with
chronic moderate to severe plaque psoriasis who are candidates for
systemic therapy. For patients with chronic moderate plaque
psoriasis, INFLECTRA should be used after phototherapy has been
shown to be ineffective or inappropriate. When assessing the
severity of psoriasis, the physician should consider the extent of
involvement, location of lesions, response to previous treatments,
and impact of disease on the patient's quality of life.
INFLECTRA is contraindicated in patients with severe infections
such as sepsis, abscesses, tuberculosis and opportunistic
infections, in patients with moderate or severe (NYHA Class III/IV)
congestive heart failure, and in patients with a history of
hypersensitivity to infliximab, to other murine proteins, or to any
of the excipients.
Tuberculosis (frequently disseminated or extrapulmonary at
clinical presentation), invasive fungal infections, and other
opportunistic infections, have been observed in patients receiving
infliximab. Some of these infections have been fatal. Patients must
be evaluated for the risk of tuberculosis, including latent
tuberculosis, prior to initiation of INFLECTRA.
Hepatosplenic T-cell lymphoma has been observed for the
reference product, infliximab, in disease populations for which
INFLECTRA has not been authorized. Lymphoma and other
malignancies, some fatal, have been reported in children and
adolescent patients treated with TNF blockers, including
infliximab.
The safety and efficacy of INFLECTRA has not been established in
pediatric patients.
INFLECTRA should not be given to patients with a clinically
important, active infection. Patients should be monitored for signs
and symptoms of infection while on or after treatment with
INFLECTRA™. New infections should be closely monitored. If a
patient develops a serious infection, INFLECTRA therapy should be
discontinued.
Lymphomas have been observed in patients treated with
TNF-blocking agents, including infliximab. Patients with rheumatoid
arthritis, particularly those with highly active disease and/or
chronic exposure to immunosuppressant therapies, may be at a higher
risk (up to several fold) for the development of lymphoma than the
general population, even in the absence of TNF-blocking therapy. In
the controlled portions of clinical trials of some TNF-blocking
agents, including infliximab, more malignancies (excluding lymphoma
and non-melanoma skin cancer [NMSC]) have been observed in patients
receiving those TNF-blockers compared with control patients. In an
exploratory clinical trial evaluating the use of infliximab in
patients with moderate to severe chronic obstructive pulmonary
disease (COPD), more malignancies were reported in infliximab
treated patients compared with control patients. All patients
had a history of heavy smoking.
The potential role of TNF-blocking therapy in the development of
malignancies is not known. Caution should be exercised when
considering TNF-blocking therapy for patients with a history of
malignancy or when considering continuing treatment in patients who
develop a malignancy.
Very rare cases of jaundice and non-infectious hepatitis, some
with features of autoimmune hepatitis, have been observed in the
post-marketing experience of the reference product REMICADE™.
Chronic carriers of hepatitis B should be appropriately evaluated
prior to the initiation of INFLECTRA therapy and monitored closely
during treatment and for several months following discontinuation
of therapy.
Infliximab has been associated with hypersensitivity reactions
that vary in their time of onset. Most hypersensitivity reactions,
which include urticaria, dyspnea, and/or hypotension, have occurred
during or within 2 hours of infliximab infusion.
Treatment with infliximab may result in the formation of
autoantibodies and, rarely, in the development of a lupus-like
syndrome. If a patient develops symptoms suggestive of a lupus-
like syndrome following treatment with infliximab, treatment should
be discontinued.
Use of live vaccines could result in clinical infections,
including disseminated infections. It is recommended that live
vaccines not be given concurrently with infliximab and that the
vaccinations of patients be brought up to date with all vaccination
guidelines prior to initiating INFLECTRA therapy.
Other uses of therapeutic infectious agents such as live
attenuated bacteria (e.g., BCG bladder instillation for the
treatment of cancer) could result in clinical infections, including
disseminated infections. It is recommended that therapeutic
infectious agents not be given concurrently with infliximab.
Women of childbearing potential must use adequate contraception
to prevent pregnancy and continue to do so for at least 6 months
after the last INFLECTRA treatment.
In studies with the reference product REMICADE, the most common
adverse drug reactions reported from both clinical trials and
post-marketing reports were infections, allergic reactions and
infusion-related reactions. One of the most common reasons for
discontinuing treatment in clinical trials was infusion-related
reactions (dyspnea, flushing, headache and rash). Please consult
the product monograph for full prescribing information.
Private Securities Litigation Reform Act of
1995 –
A Caution Concerning Forward-Looking Statements
This press release contains, or may contain, forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding Hospira's
biosimilars program and availability of Inflectra. Hospira cautions
that these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Other
factors that may affect Hospira's operations and may cause actual
results to be materially different from expectations include the
risks, uncertainties and factors discussed under the headings "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Hospira's latest Annual
Report on Form 10-K, filed with the U.S. Securities and Exchange
Commission, which are incorporated by reference. Hospira undertakes
no obligation to release publicly any revisions to forward-looking
statements as the result of subsequent events or developments,
except as required by law.
1 IMS CD&H data, 2014.
2 PLANETAS and PLANET RA 54 week trials.
3 European Commission. What you need to know about
biosimilar medicinal products: Consensus Information Paper.
Available at:
http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf.
Accessed December 10, 2013.
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visit:http://www.prnewswire.com/news-releases/hospiras-inflectra-infliximab-now-available-in-canada-300057635.html
SOURCE Hospira, Inc.