Market Overview

One Year Maintenance and Switching Data in Patients with Crohn's Disease Support the Use of INFLECTRA®* (infliximab CT-P13) in IBD1


Efficacy and safety profiles including immunogenicity were observed
to be comparable between patients maintained on INFLECTRA or REMICADE
and those switched to INFLECTRA from REMICADE

New data show that switching patients with Crohn's disease (CD) to
INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to
comparable efficacy, safety and tolerability to treatment with REMICADE
over a 24 week period.1 The full 54-week results of the
randomized controlled trial comparing INFLECTRA and REMICADE in
biologic-naïve patients with active CD support the long-term
effectiveness of treatment with INFLECTRA.1 The results also
show that INFLECTRA was well-tolerated, with a similar safety profile to
REMICADE.1 Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare
jointly announced the secondary outcomes from the phase III trial of
INFLECTRA in CD at the 25th United European Gastroenterology
(UEG) Week.

is marketed as INFLECTRA (infliximab-dyyb) in the United States (U.S.)
and under other brand names in some countries. In the EU, INFLECTRA is
marketed as INFLECTRA (infliximab CT-P13)
a U.S. registered trademark of Janssen Biotech, Inc.

"The data announced today show that 24 weeks (six months) after
switching from REMICADE to the Infliximab biosimilar CT-P13, patients
with Crohn's disease continue to experience similar efficacy, safety and
tolerability compared to staying on REMICADE," said Stephen B Hanauer,
M.D., Professor of Medicine-Gastroenterology and Hepatology, Feinberg
School of Medicine, Northwestern University, US. "These data support
previous findings which demonstrate the importance of CT-P13 as a
treatment option for patients with Crohn's disease, providing healthcare
professionals further confidence when stable patients switch to CT-P13

"These new data add to the considerable body of evidence, including
real-world studies and the NOR-SWITCH trial, for the switching of stable
patients to INFLECTRA," said Sam Azoulay, M.D., Senior Vice President,
Chief Medical Officer, Pfizer Essential Health. "Today's announcement
further highlights Pfizer's commitment to biosimilars and provides
additional evidence supporting use of INFLECTRA in Crohn's disease."

The study previously reported its primary endpoint at six weeks,
demonstrating non-inferiority of INFLECTRA compared to REMICADE in the
treatment of CD.2

More than 50 real-world studies in IBD have been conducted with
INFLECTRA, evaluating over 7,500 IBD patients in real-world settings.2,3,4,5,6,7,8,9,10,11,12,13,14
There is an important and growing body of evidence for the switching of
stable REMICADE patients to INFLECTRA. Clinical studies supporting this
switch include NOR-SWITCH,15 BIO-SWITCH,16
PROSIT-BIO3 and now CT-P13 3.4.1,2,17 For example,
the NOR-SWITCH study published earlier this year showed that switching
from REMICADE to INFLECTRA was not inferior to continued treatment with
REMICADE when measured across all adult indications.15

About the trial

This is a randomized, double-blind, parallel-group, phase III study
conducted over 54 weeks in 220 patients with active CD to compare
overall safety and efficacy between INFLECTRA and REMICADE as determined
by the Crohn's Disease Activity Index (CDAI)-70 response rates.1
The primary endpoint of the 54 week study was collected at week 6 to
demonstrate that INFLECTRA is non-inferior to REMICADE in the treatment
of CD.2 From Week 30, patients on REMICADE were randomized to
either continue on the same treatment or switch to INFLECTRA while
patients on INFLECTRA were randomized to either continue on the same
treatment or switch to REMICADE.1 Final study results were
collected at 54-weeks.1

The pre-specified secondary endpoints reported today include CDAI-70
response rates after week 6, clinical remission,[1] Short
Inflammatory Bowel Disease Questionnaire (SIBDQ)[2] results,
and safety endpoints including adverse events and immunogenicity. While
not powered to draw definitive conclusions, these new data add to the
body of evidence supporting use of INFLECTRA in the Crohn's Disease
indication, including switch to INFLECTRA from REMICADE.1
Comparable efficacy, as measured by CDAI-70 response and clinical
remission after week 6 was observed, and these response rates were
maintained and observed to be similar in all study arms at week 54.1
One-year data including adverse drug reactions, serious adverse events
and infections were observed to be similar among all treatment groups.1
There were no clinically meaningful differences in immunogenicity
results throughout the study period among treatment groups up to week 54.1


CDAI: Crohn's Disease Activity Index, a recognised measure for the
evaluation of disease activity. A response to treatment is measured as a
decrease of 70 points or greater (CDAI-70).
[1] Clinical
remission: decrease in CDAI >150 points
[2] Short
Inflammatory Bowel Disease Questionnaire, a health-related quality of
life tool measuring physical, social, and emotional status, and has been
predominantly used in trials for Crohn's disease.


Only your doctor can recommend a course of treatment after checking your
health condition. INFLECTRA (infliximab-dyyb) can cause serious side
effects such as lowering your ability to fight infections. Some
patients, especially those 65 years and older, have had serious
infections caused by viruses, fungi or bacteria that have spread
throughout the body, including tuberculosis (TB) and histoplasmosis.
Some of these infections have been fatal. Your doctor should monitor you
closely for signs and symptoms of TB during treatment with INFLECTRA.

Unusual cancers have been reported in children and teenage patients
taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form
of fatal lymphoma, has occurred mostly in teenage or young adult males
with Crohn's disease or ulcerative colitis who were taking infliximab
products and azathioprine or 6-mercaptopurine. 
children and adults taking TNF blockers, including INFLECTRA, the
chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with
your doctor.

What should I tell my doctor before I take INFLECTRA?

You should let your doctor know if you have or ever had any of the

  • Tuberculosis (TB) or have been near someone who has TB. Your doctor
    will check you for TB with a skin test. If you have latent (inactive)
    TB, you will begin TB treatment before you start INFLECTRA.
  • Lived in a region where certain fungal infections like histoplasmosis
    or coccidioidomycosis are common.
  • Infections that keep coming back, diabetes, or an immune system
  • Any type of cancer or a risk factor for developing cancer, for
    example, chronic obstructive pulmonary disease (COPD) or had
    phototherapy for psoriasis.
  • Heart failure or any heart condition. Many people with heart failure
    should not take INFLECTRA.
  • Hepatitis B virus (HBV) infection or think you may be a carrier of
    HBV. Your doctor will test you for HBV.
  • Nervous system disorders (like multiple sclerosis or Guillain-Barré

Also tell your doctor if you:

  • Use the medicines Kineret (anakinra), Orencia (abatacept), or Actemra
    (tocilizumab) or other medicines called biologics used to treat the
    same problems as INFLECTRA.
  • Are pregnant, plan to become pregnant, are breast-feeding, or have a
    baby and were using INFLECTRA during your pregnancy. Tell your baby's
    doctor about your INFLECTRA use. If your baby receives a live vaccine
    within 6 months after birth, your baby may develop infections with
    serious complications that can lead to death.
  • Recently received or are scheduled to receive a vaccine. Adults and
    children taking INFLECTRA should not receive live vaccines or
    treatment with a weakened bacteria (such as BCG for bladder cancer)
    while taking INFLECTRA.

What should I watch for and talk to my doctor about before or while

The following serious (sometimes fatal) side effects have been reported
in people taking INFLECTRA.

You should tell your doctor right away if you have any of the signs
listed below:

  • Infections (like TB, blood infections, pneumonia)—fever, tiredness,
    cough, flu, or warm, red, or painful skin or any open sores. INFLECTRA
    can make you more likely to get an infection or make any infection
    that you have worse.
  • Lymphoma or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Heart failure—new or worsening symptoms, such as shortness of breath,
    swelling of your ankles or feet, or sudden weight gain.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever,
    skin rash, and/or joint pain.
  • Liver injury—jaundice (yellow skin and eyes), dark brown urine,
    right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders—fever that doesn't go away, bruising, bleeding, or
    severe paleness.
  • Nervous system disorders—numbness, weakness, tingling, changes in your
    vision, or seizures.
  • Allergic reactions during or after the infusion—hives, difficulty
    breathing, chest pain, high or low blood pressure, swelling of face
    and hands, and fever or chills.
  • Lupus-like syndrome—chest discomfort or pain that does not go away,
    shortness of breath, joint pain, rash on the cheeks or arms that gets
    worse in the sun.
  • Psoriasis—new or worsening psoriasis such as red scaly patches or
    raised bumps on the skin that are filled with pus.

The more common side effects with infliximab products are respiratory
infections (that may include sinus infections and sore throat),
headache, rash, coughing, and stomach pain.

INFLECTRA is a prescription medication used to treat:

Crohn's Disease

  • Can reduce signs and symptoms and induce and maintain remission in
    adult patients with moderately to severely active Crohn's disease who
    haven't responded well to other therapies

Paediatric Crohn's Disease

  • Can reduce signs and symptoms and induce and maintain remission in
    children (ages 6-17) with moderately to severely active Crohn's
    disease who haven't responded well to other therapies

Ulcerative Colitis

  • Can reduce signs and symptoms, induce and maintain remission, promote
    intestinal healing, and reduce or stop the need for steroids in adult
    patients with moderately to severely active ulcerative colitis who
    haven't responded well to other therapies

Rheumatoid Arthritis

  • Can reduce signs and symptoms, help stop further joint damage, and
    improve physical function in patients with moderately to severely
    active rheumatoid arthritis, in combination with methotrexate

Ankylosing Spondylitis

  • Can reduce signs and symptoms in patients with active ankylosing

Psoriatic Arthritis

  • Can reduce signs and symptoms of active arthritis, help stop further
    joint damage, and improve physical function in patients with psoriatic

Plaque Psoriasis

  • Approved for the treatment of adult patients with chronic severe
    (extensive and/or disabling) plaque psoriasis under the care of a
    physician who will determine if INFLECTRA is appropriate considering
    other available therapies

Please see full
Prescribing Information

About Pfizer: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
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In addition, to learn more, please visit us on and
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DISCLOSURE NOTICE: The information contained in this release is as of
October 30, 2017. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.

This release contains forward-looking information about INFLECTRA
(infliximab-dyyb), including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, uncertainties
regarding the commercial success of INFLECTRA; uncertainties regarding
the outcome and impact of the suit filed against Johnson & Johnson; the
uncertainties inherent in research and development, including, without
limitation, the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; intellectual property and/or litigation
implications; relationship with the application sponsor; decisions by
regulatory authorities regarding labeling and other matters that could
affect the availability or commercial potential of INFLECTRA; and
competitive developments.

A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December
31, 2016, including in the sections thereof captioned "Risk Factors" and
"Forward-Looking Information and Factors That May Affect Future
Results", as well as in its subsequent reports on Form 10-Q and Form
8-K, all of which are filed with the U.S. Securities and Exchange
Commission and available at

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