Company to Begin Shipping to Wholesalers in
Late November, 2016
Pfizer Inc. (NYSE:PFE) announced today that the company will
begin shipment of INFLECTRA® (infliximab-dyyb)for injection,
a biosimilar of REMICADE®1 (infliximab) to wholesalers in the
United States (U.S.) in late November 2016.
INFLECTRA will be the first biosimilar monoclonal antibody (mAb)
and only the second biosimilar to be available in the U.S. It is
approved for the treatment of:
- adult patients and pediatric patients
(ages six years and older) with moderate to severely active Crohn’s
disease who have had an inadequate response to conventional
therapy;
- adult patients with moderate to
severely active ulcerative colitis who have had an inadequate
response to conventional therapy; and
- moderate to severely active rheumatoid
arthritis in combination with methotrexate; active ankylosing
spondylitis; active psoriatic arthritis; and chronic severe plaque
psoriasis.
“Biologics have revolutionized the treatment of many
life-threatening and chronic diseases. By introducing INFLECTRA to
the U.S. marketplace, Pfizer is helping customers access an
additional high quality treatment option that promises greater
savings for the healthcare system,” said Diem Nguyen, regional
president North America, Pfizer Essential Health Business. “We are
proud of our global leadership in biosimilars, and will continue
our efforts to advance a sustainable, competitive marketplace for
these therapies to deliver a high quality, consistent supply of
product and long-term savings and value for patients and
physicians.”
Pfizer holds exclusive commercialization rights to Celltrion’s
INFLECTRA in the U.S., and has already successfully introduced
INFLECTRA in other markets across the globe.
INFLECTRA will be introduced at a 15% discount to the current
wholesaler acquisition cost (WAC) of REMICADE®, its reference
product. WAC is not inclusive of discounts to payers, providers,
distributors and other purchasing organizations.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
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. For 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 following:
- 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 problem.
- 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 syndrome).
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 taking INFLECTRA®?
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
Pediatric 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 spondylitis
Psoriatic Arthritis
- Can reduce signs and symptoms of active
arthritis, help stop further joint damage, and improve physical
function in patients with psoriatic arthritis
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 for
INFLECTRA® (infliximab-dyyb).
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 health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of October 17, 2016. 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), the timing of Pfizer’s planned
shipment of INFLECTRA to wholesalers in the United States and
Pfizer’s plans with respect to biosimilars, including their
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, risks related to the
ability to meet anticipated shipment dates; uncertainties regarding
the commercial success of INFLECTRA; the uncertainties inherent in
research and development; 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, 2015, 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 www.sec.gov
and www.pfizer.com.
__________
1 REMICADE® is a U.S. registered trademark
of Janssen Biotech, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20161017006422/en/
Pfizer Inc.Media Contact:Rachel Hooper,
916-708-1868Rachel.Hooper@Pfizer.comorInvestor Contact:Ryan Crowe,
212-733-8160Ryan.Crowe@Pfizer.com
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