- The new independent clinical study data presented at
EULAR's annual congress this week adds to the growing wealth of
data for Hospira's Inflectra (infliximab), the first biosimilar
monoclonal antibody, which received approval from the European
Commission in 2013
- Inflectra provides a potentially cost effective
treatment option for people suffering from severe diseases such as
rheumatoid arthritis (RA) and ankylosing spondylitis (AS), while
maintaining comparable quality, efficacy and safety to the
reference infliximab
- The large savings expected to be generated with
biosimilars provide an opportunity to improve patient access to
life-changing medicines
- Additional abstract reveals data showing no meaningful
differences in safety (infections, serious infections,
malignancies/lymphoma, infusion-related reactions) between patients
treated with Inflectra and Remicade
ROME, June 10, 2015 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), a global leader in biosimilars, today announced the
results of an independent clinical study, showing patients with
rheumatic diseases experienced comparable clinical effectiveness
and safety after switching from Remicade™ to Inflectra. The study
entitled, "Clinical experience with infliximab biosimilar –
switch from Remicade. Abstract SAT0174," supports the
use of Inflectra, the first biosimilar monoclonal antibody approved
in the EU, as a treatment option for people suffering from
inflammatory conditions such as rheumatoid arthritis, who are
currently receiving stable treatment with reference
infliximab.1
The data, presented at the European League Against Rheumatism
Annual Congress (EULAR 2015), compared outcomes in 39 patients
after a mean of four years of treatment with Remicade, with the
outcomes of those same patients after a median of 11 months
following a switch to Inflectra.1 Patient symptoms and
disease activity were similar before and after the switch between
the two treatments, and no immediate safety signals were
observed.1 Full details of the study can be found at:
https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252112
"This post-market study shows that patients with various
rheumatic conditions who are stable on Remicade treatment don't
experience a loss of effectiveness or unexpected side effects when
switched to biosimilar infliximab," said Dr. Tuulikki Sokka, Head of Rheumatology at
Jyväskylä Central Hospital, Finland, and author of the study. "Real world
studies such as this can help provide additional confidence in
biosimilars, giving clinicians an opportunity to reduce healthcare
spending and provide greater access to biologic medicines for
patients in need."
In addition, the results of a meta-analysis of 14 randomised
controlled trials assessing safety incidences in 1,454 patients
were announced at EULAR. The abstract is titled, "Meta-analysis
of the safety data between infliximab biosimilar (CT-P13) and
innovator infliximab in rheumatoid arthritis and ankylosing
spondylitis. Abstract AB0433." This analysis compared the
safety profile of Inflectra from clinical trials in RA and AS, with
historical safety data from Remicade clinical trials. The results
revealed no meaningful differences in safety (infections, serious
infections, malignancies/lymphoma, infusion-related reactions)
between patients treated with Inflectra and
Remicade.2
"The study presented at EULAR today provides assurance that
switching to Inflectra is a viable, effective treatment alternative
to maintenance with Remicade," said Paul
Audhya, M.D., Vice President, Medical Affairs, Europe, Middle
East and Africa,
Hospira.
It has been estimated that 40 percent of RA patients in
Europe have severely restricted
access to biologics due to the high cost of treatment, with large
variations in patient access levels seen across Europe.3 The potential cost savings
from biosimilars for healthcare systems could improve patient
access to these life-changing medications. A recent study looked at
the estimated savings expected from switching RA patients from
Remicade to biosimilar infliximab in six countries in Central and
Eastern Europe. The study showed
that 1,200-1,800 additional RA patients could be treated over a
three-year period if the savings of between €15.3-20.8M were spent
on reimbursement of additional biosimilar infliximab
treatment.4
"With more and more people living with chronic diseases, such as
RA, the strain on our healthcare economy is only going to increase.
Hospira is committed to delivering high quality, biosimilar
medicines at a lower cost than the reference product, to increase
patient access to biologic medicines," said Paul Greenland, Vice President Biologics,
Hospira.
Inflectra received its authorization from the European
Commission (EC) in September 2013 for
all the licensed indications of Remicade, which has been authorized
in the EU since 1999 and recorded European sales of almost €2
billion in 2013.5 Inflectra is now available in 26
European countries, launching in 13 new markets earlier this year,
following the patent expiry of Remicade. Inflectra is also
available in Canada, has recently
been approved by the regulatory authority, ANVISA, in Brazil, and has been submitted to the U.S.
Food and Drug Administration (FDA) for approval.
With one of the largest biosimilar pipelines in the industry,
Hospira has more than seven years' market experience in biosimilars
in the EU. The company has several biosimilars on the European
market, including Inflectra (infliximab), Retacrit™
(epoetin zeta) and Nivestim™ (filgrastim). Hospira has delivered
more than 10 million doses of biosimilar medicines to patients
worldwide.6
About Biosimilars
Biosimilar medicines are biologics with comparable quality,
safety and efficacy as their reference biologics, but are provided
at a lower cost. Biosimilars undergo an extensive comparability
exercise with the reference product and, based on the totality of
evidence submitted to the regulatory body, the biosimilar may be
approved for all the licensed indications of the reference
biologic, and launched after patent expiry of the reference
product.7
About Inflectra8
Inflectra (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 alpha (TNF
beta). Inflectra is indicated for:
Rheumatoid arthritis
Inflectra, in combination with methotrexate, is indicated for
the reduction of signs and symptoms as well as the improvement in
physical function in:
- adult patients with active disease when the response to
disease‑modifying antirheumatic drugs (DMARDs), including
methotrexate, has been inadequate.
- adult patients with severe, active and progressive disease not
previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured by X‑ray, has been
demonstrated.
Adult Crohn's disease
Inflectra is indicated for:
- treatment of moderately to severely active Crohn's disease, in
adult patients who have not responded despite a full and adequate
course of therapy with a corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such therapies.
- treatment of fistulising, active Crohn's disease, in adult
patients who have not responded despite a full and adequate course
of therapy with conventional treatment (including antibiotics,
drainage and immunosuppressive therapy).
Paediatric Crohn's disease
Inflectra is indicated for treatment of severe, active Crohn's
disease in children and adolescents aged six to 17 years, who have
not responded to conventional therapy including a corticosteroid,
an immunomodulator and primary nutrition therapy; or who are
intolerant to or have contraindications for such therapies.
Infliximab has been studied only in combination with conventional
immunosuppressive therapy.
Ulcerative colitis
Inflectra is indicated for treatment of moderately to severely
active ulcerative colitis in adult patients who have had an
inadequate response to conventional therapy including
corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA),
or who are intolerant to or have medical contraindications for such
therapies.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active
ulcerative colitis in children and adolescents aged six to 17
years, who have had an inadequate response to conventional therapy
including corticosteroids and 6‑MP or AZA, or who are intolerant to
or have medical contraindications for such therapies.
Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active
ankylosing spondylitis, in adult patients who have responded
inadequately to conventional therapy.
Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive
psoriatic arthritis in adult patients when the response to previous
DMARD therapy has been inadequate.
Inflectra should be administered
- in combination with methotrexate
- or alone in patients who show intolerance to methotrexate or
for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in
patients with psoriatic arthritis, and to reduce the rate of
progression of peripheral joint damage as measured by X‑ray in
patients with polyarticular symmetrical subtypes of the
disease.
Psoriasis
Inflectra is indicated for treatment of moderate to severe
plaque psoriasis in adult patients who failed to respond to, or who
have a contraindication to, or are intolerant to other systemic
therapy including cyclosporine, methotrexate or psoralen
ultra-violet A (PUVA).
See the Summary of Product Characteristics (also part of the
EPAR) for full details.
Important Safety Information
There are reports of serious infections, including tuberculosis
(TB), sepsis and pneumonia, in patients taking Inflectra. Some of
these infections have been fatal. Patients should tell their
doctors if they have had recent or past exposure to people with TB.
Their doctors will evaluate them for TB and may perform tests for
TB. If patients have latent (inactive) TB, their doctors should
begin TB treatment before they start Inflectra. Inflectra can lower
patients' ability to fight infections, so if they are prone to or
have a history of infections, or develop any signs of an infection
such as fever, fatigue, cough, flu-like symptoms or warm, red or
painful skin while taking Inflectra, patients should tell their
doctors right away. Also, patients should tell their doctors if
they are scheduled to receive a vaccine or if they have lived in a
region where histoplasmosis, blastomycosis or coccidioidomycosis
are common.
Reports of a type of blood cancer called lymphoma in patients on
Inflectra or other TNF blockers are rare, but occur more often than
expected for people in general. People who have been treated for
rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or
psoriatic arthritis for a long time, particularly those with highly
active disease may be more prone to develop lymphoma. Cancers,
other than lymphoma, have also been reported. Rarely, children and
young adults who have been treated for Crohn's disease or
ulcerative colitis with Inflectra in combination with azathioprine
or 6-mercaptopurine have developed a rare type of lymphoma,
hepatosplenic T cell lymphoma (HSTCL) that often results in death.
Patients taking Inflectra or other TNF blockers may be at an
increased risk for developing lymphoma or other cancers. Patients
should also tell their doctors if they have had or develop lymphoma
or other cancers or if they have a lung disease called chronic
obstructive pulmonary disease (COPD).
Many people with heart failure should not take Inflectra; so
prior to treatment they should discuss any heart condition with
their doctors. Patients should tell their doctors right away if
they develop new or worsening symptoms of heart failure (such as
shortness of breath, swelling of ankles or feet, or sudden weight
gain).
Reactivation of hepatitis B virus has been reported in patients
who are carriers of this virus and are taking TNF blockers, such as
Inflectra. Some of these cases have been fatal. All patients should
be screened for signs of an infection and a hepatitis B expert
should be consulted if a patient tests positive for hepatitis B
surface antigen.
There have been rare cases of serious liver injury in people
taking infliximab, some fatal. Patients should tell their doctors
if they have liver problems and contact their doctors immediately
if they develop symptoms such as jaundice (yellow skin and eyes),
dark brown urine, right-sided abdominal pain, fever, or severe
fatigue.
Blood disorders in people taking Inflectra have been reported,
some fatal. Patients should tell their doctors if they develop
possible signs of blood disorders such as persistent fever,
bruising, bleeding, or paleness while taking Inflectra. Nervous
system disorders have also been reported. Patients should tell
their doctors if they have or have had a disease that affects the
nervous system, or if they experience any numbness, weakness,
tingling, visual disturbances or seizures while taking
Inflectra.
Allergic reactions, some severe have been reported during or
after infusions with infliximab. Signs of an allergic reaction
include hives, difficulty breathing, chest pain, high or low blood
pressure, swelling of face and hands, and fever or chills.
Inflectra should not be administered to patients with known
hypersensitivity to Inflectra or any component of Inflectra.
Patients should tell their doctors if they have experienced a
severe allergic reaction. The most common side effects of Inflectra
are: viral infections, headache, upper respiratory-tract infection,
sinusitis, nausea, abdominal pain, infusion-related reactions and
pain.
See the Summary of Product Characteristics (also part of the
EPAR) for full details.
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.
Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding Hospira's biosimilars program
and approval in Europe of
Inflectra. Hospira cautions that these forward-looking statements
are subject to risks and uncertainties, including adequate and
sustained progress on the company's quality initiatives and device
strategy that may cause actual results to differ materially from
those indicated in the forward-looking statements. Economic,
competitive, governmental, regulatory, legal, technological,
manufacturing supply, quality, modernizing and streamlining
activities, and 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 and subsequent
Quarterly Reports on Forms 10-Q, 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.
References
1 Sokka T. Clinical experience with infliximab
biosimilar – switch from Remicade. Abstract SAT0174. Presented
June 2015 at EULAR, Rome, Italy. Available at
https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252112
2 Park W, Yoo D H, Suh C H et al. Meta-analysis of the
safety data between infliximab biosimilar (CT-P13) and innovator
infliximab in rheumatoid arthritis and ankylosing spondylitis.
Abstract AB0433. Presented June 2015
at EULAR, Rome, Italy. Available
at
https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=256121
3 Putrik P, Ramiro S, Kvien TK et al. Inequities in
access to biologic and synthetic DMARDs across 46 European
countries. Ann Rheum Dis. 2014. Jan; 73(1): 198-206.
4 Brodszky V., Baji P., Balogh O and Pentek M. Budget
impact analysis of biosimilar infliximab (CT-P13) for the treatment
of rheumatoid arthritis in six Central and Eastern European
countries. Eur J Health Econ (2014) 15 (Suppl 1):S65–S71.
5 Merck and Co, 2013 Annual Report, available from:
http://www.merck.com/investors/financials/form-10-k-2013.pdf.
Accessed May 2015.
6 Hospira, Inc., 2014, Data on file.
7 European Commission. Consensus Information Paper 2013.
What you need to know about Biosimilar Medicinal Products.
Available at
http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf Accessed
May 2015.
8 Inflectra (infliximab). Summary of Product
Characteristics. 2014.