Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for Adalimumab-adbm injection, Boehringer's biosimilar to Humira®

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

[email protected]

Lauren Casparis

VP, Communications, GoodRx

[email protected]

415.847.1422

 

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.