First biosimilar with an exclusive low cash
price on the GoodRx platform
RIDGEFIELD, Conn. and SANTA MONICA, Calif., July 18,
2024 /PRNewswire/ -- Boehringer Ingelheim and
GoodRx (Nasdaq: GDRX), the leading prescription savings platform in
the U.S., announced today a patient affordability initiative to
provide citrate-free Adalimumab-adbm, Boehringer's biosimilar to
Humira® (adalimumab), at a low cash price available
exclusively on GoodRx. This program is a significant step in
addressing access and affordability in one of the largest
therapeutic categories with a high cost burden for patients.
Adalimumab-adbm is an FDA-approved interchangeable* biosimilar
to Humira®. The citrate-free, injectable medication is
used to treat or reduce the signs and symptoms of certain
autoimmune conditions, such as rheumatoid arthritis, Crohn's
disease, psoriatic arthritis, and ulcerative colitis. By working
together to offer consumers a low cash price, the companies are
broadening access and affordability for this critical drug. Now,
anyone with a valid prescription, regardless of insurance status,
can use GoodRx to purchase Adalimumab-adbm at over 70,000 retail
pharmacies nationwide. This may help speed up the time to therapy
for patients, which can be one of the big challenges faced with
biologic drugs.
"Patients with certain chronic inflammatory diseases who do not
have insurance or are underinsured may not be able to afford
essential biologic medicines, including biosimilars, to treat their
disease," said Chris Marsh, Senior
Vice President of Value and Access at Boehringer Ingelheim.
"Partnering with GoodRx to offer our biosimilar Adalimumab-adbm at
a low price to these patients helps us deliver on our commitment to
lowering financial barriers and improving access to critical
treatments."
Beginning today, July 18,
Boehringer and GoodRx are offering prices for both
high-concentration and low-concentration citrate-free formulations
of Adalimumab-adbm as a pre-filled syringe (10 mg/0.2 mL, 20 mg/0.4
mL, 40 mg/0.8 mL or 40 mg/0.4 mL) or autoinjector (40 mg/0.8 mL or
40 mg/0.4 mL) at an exclusive cost of $550 per two-pack, which represents a 92%
discount from the Humira list price.
"For over a decade, GoodRx has been working to help reduce the
costs of medications for patients, and we recognize the critical
need for ensuring biosimilars are affordable to all," said
Dorothy Gemmell, Chief Commercial
Officer at GoodRx. "We're excited to leverage the reach and scale
of the GoodRx platform to help address this access gap and make
Adalimumab-adbm more accessible to patients."
GoodRx works with nearly 150 brands across pharmaceutical
manufacturers, medical device companies and OTC medicines to
surface their savings and patient support programs directly with
high-intent audiences via the GoodRx platform. In addition to
retail and specialty medications, the company started offering a
low cash price for a popular insulin last fall, and is now excited
to expand into biosimilars to help consumers find more affordable
ways to access the treatments they need.
More details on this offering are available at
www.goodrx.com/adbm.
*The FDA has approved Adalimumab-adbm (50 mg/mL) as an
interchangeable biosimilar. Adalimumab-adbm (100 mg/mL) has not yet
been designated as interchangeable. For more information on
interchangeability for Adalimumab-adbm, please refer to the Purple
Book: https://purplebooksearch.fda.gov/.
Please see Important Safety Information below and the
Adalimumab-adbm Prescribing Information, including BOXED WARNING
and Medication Guide.
About Biosimilars
A biosimilar is a biologic medicine
that is developed to be highly similar to an approved reference
biologic, with no clinically meaningful differences in terms of
safety, potency and purity.
A biosimilar with an interchangeable designation, which is
designated by the FDA, may be auto-substituted for the reference
product by a pharmacist. Individual state laws control how and
whether providers and patients must be notified. An interchangeable
biosimilar first must meet the high FDA standards of a biosimilar.
Then, to achieve the interchangeable designation, the FDA requires
additional data, which may include a study of multiple
substitutions in patients, known as a switching study. The study
must show that patients can be switched with no increased risk in
terms of safety or diminished efficacy compared with remaining on
the reference product in any given patient.
About Boehringer Ingelheim in Biologics and
Biosimilars
Through novel biologics and our biosimilar, we
strive to increase the availability of safe, effective,
high-quality therapeutic options to patients worldwide.
Boehringer Ingelheim is one of the largest producers of biologic
medicines in the world, producing biologic medicines to support our
diverse pipeline, as well as other companies' biopharmaceuticals on
a contract basis. As a pioneer in biologics, to date, Boehringer
Ingelheim's Biopharmaceutical Contract Manufacturing business has
supported our customers to bring dozens of biologics to the market
in therapeutic areas that include oncology, immunology and
cardiovascular indications. For more information about Boehringer
Ingelheim's Biopharma and manufacturing capabilities, please click
here:
https://www.boehringer-ingelheim.com/us/biopharma/biosimilars.
About GoodRx
GoodRx is the leading prescription
savings platform in the U.S. Trusted by more than 25 million
consumers and 750,000 healthcare professionals annually, GoodRx
provides access to savings and affordability options for generic
and brand-name medications at more than 70,000 pharmacies
nationwide, as well as comprehensive healthcare research and
information. Since 2011, GoodRx has helped consumers save nearly
$75 billion on the cost of their
prescriptions.
GoodRx periodically posts information that may be important
to investors on its investor relations website at
https://investors.goodrx.com. We intend to use our website as a
means of disclosing material nonpublic information and for
complying with our disclosure obligations under Regulation FD.
Accordingly, investors and potential investors are encouraged to
consult GoodRx's website regularly for important information, in
addition to following GoodRx's press releases, filings with the
Securities and Exchange Commission (the "SEC") and public
conference calls and webcasts. The information contained on, or
that may be accessed through, GoodRx's website is not incorporated
by reference into, and is not a part of, this press
release.
GoodRx Forward-Looking Statements
This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including, without limitation, statements regarding consumer
savings and accessibility; the benefits of GoodRx's offerings to
consumers, GoodRx and GoodRx's partners; and GoodRx's plans,
expectations and objectives. These statements are neither promises
nor guarantees, but involve known and unknown risks, uncertainties
and other important factors that may cause GoodRx's actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to,
risks relating to GoodRx's ability to achieve broad market
education and change consumer purchasing habits, changes in
medication pricing and pricing structures, GoodRx's reliance on a
limited number of industry participants, the competitive nature of
GoodRx's industry and the important factors discussed under the
caption "Risk Factors" in our Annual Report on Form 10-K for the
year ended December 31, 2023, and our
other filings with the SEC. These factors could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent GoodRx management's estimates
as of the date of this press release. While GoodRx may elect to
update such forward-looking statements at some point in the future,
it disclaims any obligation to do so, even if subsequent events
cause its views to change.
What is Adalimumab-adbm?
This information also applies to CYLTEZO®
(adalimumab-adbm) injection for subcutaneous use.
Adalimumab-adbm is a medicine called a tumor necrosis factor
(TNF) blocker. Adalimumab-adbm is used:
- To reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults.
Adalimumab-adbm can be used alone, with methotrexate, or with
certain other medicines.
- moderate to severe polyarticular juvenile idiopathic
arthritis (JIA) in children 2 years and older.
Adalimumab-adbm can be used alone or with methotrexate.
- psoriatic arthritis (PsA) in adults. Adalimumab-adbm can
be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe hidradenitis suppurativa (HS) in
adults.
- To treat moderate to severe Crohn's disease (CD) in adults
and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in
adults. It is not known if adalimumab products are effective in
people who stopped responding to or could not tolerate TNF-blocker
medicines.
- To treat moderate to severe chronic (lasting a long time)
plaque psoriasis (Ps) in adults who have the condition in many
areas of their body and who may benefit from taking injections or
pills (systemic therapy) or phototherapy (treatment using
ultraviolet light alone or with pills).
- To treat non-infectious intermediate, posterior, and
panuveitis in adults.
Important Safety Information for Adalimumab-adbm injection,
for subcutaneous use
This important information also applies to
CYLTEZO® (adalimumab-adbm) injection for subcutaneous
use.
What is the most important information I should know about
Adalimumab-adbm?
You should discuss the potential benefits and risks of
Adalimumab-adbm with your doctor. Adalimumab-adbm is a TNF-blocker
medicine that can lower the ability of your immune system to fight
infections. You should not start taking Adalimumab-adbm if you have
any kind of infection unless your doctor says it is okay.
- Serious infections have happened in people taking adalimumab
products. These serious infections include tuberculosis (TB) and
infections caused by viruses, fungi, or bacteria that have spread
throughout the body. Some people have died from these
infections. Your doctor should test you for TB before starting
Adalimumab-adbm and check you closely for signs and symptoms of TB
during treatment with Adalimumab-adbm, even if your TB test was
negative. If your doctor feels you are at risk, you may be treated
with medicine for TB.
- Cancer. For children and adults taking TNF blockers,
including Adalimumab-adbm, the chances of getting lymphoma or other
cancers may increase. There have been cases of unusual cancers in
children, teenagers, and young adults using TNF blockers. Some
people have developed a rare type of cancer called hepatosplenic
T-cell lymphoma. This type of cancer often results in death. If
using TNF blockers, including Adalimumab-adbm, your chances of
getting two types of skin cancer (basal cell and squamous cell) may
increase. These types are generally not life-threatening if
treated; tell your doctor if you have a bump or open sore that
doesn't heal.
What should I tell my doctor BEFORE starting
Adalimumab-adbm?
Tell your doctor about all of your health conditions,
including if you:
- Have an infection, are being treated for infection, or have
symptoms of an infection.
- Get a lot of infections or have infections that keep coming
back.
- Have diabetes.
- Have TB or have been in close contact with someone with TB, or
were born in, lived in, or traveled where there is more risk for
getting TB.
- Live or have lived in an area (such as the Ohio and Mississippi River valleys) where
there is an increased risk for getting certain kinds of fungal
infections, such as histoplasmosis, coccidioidomycosis, or
blastomycosis. These infections may happen or become more severe if
you use Adalimumab-adbm. Ask your doctor if you are unsure whether
you have lived in an area where these infections are common.
- Have or have had hepatitis B.
- Are scheduled for major surgery.
- Have or have had cancer.
- Have numbness or tingling or a nervous system disease such as
multiple sclerosis or Guillain-Barré syndrome.
- Have or had heart failure.
- Have recently received or are scheduled to receive a vaccine.
Adalimumab-adbm patients may receive vaccines, except for live
vaccines. Children should be brought up to date on all vaccines
before starting Adalimumab-adbm.
- Are allergic to rubber or latex.
- Are allergic to any Adalimumab-adbm ingredients.
- Are pregnant, planning to become pregnant, breastfeeding, or
planning to breastfeed.
- Have a baby and you were using Adalimumab-adbm during your
pregnancy. Tell your baby's doctor before your baby receives any
vaccines.
Also tell your doctor about all the medicines you take.
You should not take Adalimumab-adbm with ORENCIA®
(abatacept), KINERET® (anakinra), REMICADE®
(infliximab), ENBREL® (etanercept), CIMZIA®
(certolizumab pegol), or SIMPONI® (golimumab). Tell your
doctor if you have ever used RITUXAN® (rituximab),
IMURAN® (azathioprine), or PURINETHOL®
(mercaptopurine, 6-MP).
What should I watch for AFTER starting
Adalimumab-adbm?
Adalimumab-adbm can cause serious side effects,
including:
- Serious infections. These include TB and infections
caused by viruses, fungi, or bacteria. Symptoms related to TB
include a cough, low-grade fever, weight loss, or loss of body fat
and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms
include muscle aches, feeling very tired, dark urine, skin or eyes
that look yellow, little or no appetite, vomiting, clay-colored
bowel movements, fever, chills, stomach discomfort, and skin
rash.
- Allergic reactions. Symptoms of a serious allergic
reaction include hives; trouble breathing; and swelling of your
face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include
numbness or tingling, problems with your vision, weakness in your
arms or legs, and dizziness.
- Blood problems (decreased blood cells that help fight
infections or stop bleeding). Symptoms include a fever that does
not go away, bruising or bleeding very easily, or looking very
pale.
- Heart failure (new or worsening). Symptoms include
shortness of breath, swelling of your ankles or feet, and sudden
weight gain.
- Immune reactions, including a lupus-like syndrome.
Symptoms include chest discomfort or pain that does not go away,
shortness of breath, joint pain, or rash on your cheeks or arms
that gets worse in the sun.
- Liver problems. Symptoms include feeling very tired,
skin or eyes that look yellow, poor appetite or vomiting, and pain
on the right side of your stomach (abdomen). These problems can
lead to liver failure and death.
- Psoriasis (new or worsening). Symptoms include red scaly
patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you
develop any of the above symptoms.
The most common side effects of Adalimumab-adbm include
injection site reactions (pain, redness, rash, swelling,
itching, or bruising), upper respiratory infections (sinus
infections), headaches, and rash. These are not all the
possible side effects with Adalimumab-adbm. Tell your doctor if you
have any side effect that bothers you or that does not go away.
Remember to tell your doctor right away if you have an
infection or symptoms of an infection, including:
- Fever, sweats, or chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
- Weight loss
These are not all the possible side effects of Adalimumab-adbm.
For more information, speak with your doctor or
pharmacist.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
CL-CTZ-100018 SEPT 2023
Please see the Adalimumab-adbm Prescribing Information,
including BOXED WARNING and Medication Guide.
About Boehringer Ingelheim
Boehringer Ingelheim is a
biopharmaceutical company active in both human and animal health.
As one of the industry's top investors in Research and Development,
the company focuses on developing innovative therapies in areas of
high unmet medical need. Independent since its foundation in 1885,
Boehringer takes a long-term perspective, embedding sustainability
along the entire value chain. More than 53,500 employees serve over
130 markets to build a healthier, more sustainable, and equitable
tomorrow. Discover more
at www.boehringer-ingelheim.com/us.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses
the Cyltezo® trademark under license. The other
trademarks referenced above are owned by third parties not
affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.
MPR-US-103177 06/24
Contacts:
Taylor Pepe
Senior Associate Director, Human Pharma Communications, Boehringer
Ingelheim
taylor.pepe@boehringer-ingelheim.com
Lauren Casparis
VP, Communications, GoodRx
lcasparis@goodrx.com
415.847.1422
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.