Boehringer Ingelheim expands access to adalimumab-adbm injection, the company's biosimilar to Humira®

• Under agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent Pharmaceuticals
• Agreement supports Boehringer Ingelheim's commitment to providing affordable medications to patients

RIDGEFIELD, Conn., May 13, 2024 /PRNewswire/ -- Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer's biosimilar to Humira® (adalimumab), in the U.S.

"Boehringer Ingelheim is dedicated to broadening access to essential biologic medicines, and our collaboration with Quallent will increase availability of our adalimumab biosimilar for patients living with certain chronic inflammatory diseases," said Chris Marsh, Senior Vice President of Value and Access at Boehringer Ingelheim. "The utilization of biosimilars such as adalimumab-adbm provides the potential for more patients to benefit from biologic medicines and saves costs for both patients and the U.S. healthcare system overall. We're committed to helping the biosimilar market reach its potential, and this partnership is an important step in enabling greater adoption of these lower-cost options."

Under the terms of the agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent. Boehringer Ingelheim will continue to commercialize Boehringer Ingelheim-labeled Cyltezo® (adalimumab-adbm) injection and Adalimumab-adbm.

"We are pleased to be working with Boehringer Ingelheim to bring adalimumab-adbm to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access," said John Caulfield, President of Quallent Pharmaceuticals Health, LLC. "Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal."

Quallent will be offering both high-concentration (40 mg/0.4 mL) and low-concentration (40 mg/0.8 mL) citrate-free formulations of adalimumab-adbm as a pre-filled syringe or pen. Adalimumab-adbm's interchangeability designation* for the low-concentration formulation will extend to Quallent's 40 mg/0.8 mL private-labeled adalimumab-adbm.

*For more information on interchangeability for adalimumab-adbm, please refer to the Purple Book: https://purplebooksearch.fda.gov/.

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.

Please see CYLTEZO Prescribing Information, including BOXED WARNING, and Medication Guide; and Adalimumab-adbm Prescribing Information, including BOXED WARNING and Medication Guide.

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 CYLTEZO Prescribing Information, including BOXED WARNING, and Medication Guide; and 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-103110 05/24

Taylor Pepe
Senior Associate Director, Human Pharma Communications
[email protected]

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.