"We understand that finding affordable medications is a persistent challenge for many, which is why we strive to ensure our products are widely accessible," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. "Biosimilars are intended to contribute to the economic sustainability of healthcare systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases." Adalimumab-adbm is interchangeable* to Humira and is a citrate-free formulation, available as 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL pre-filled syringes and as a 40 mg/0.8 mL pre-filled autoinjector. *Interchangeable for the conditions of use, strengths, dosage forms, and routes of administration described in its full Prescribing Information.
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.
Through novel biologics and our interchangeable 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. For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
To reduce the signs and symptoms of:
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
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. Tell your doctor about all of your health conditions, including if you:
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. Are scheduled for major surgery.
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 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. 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. 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. 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.
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: Warm, red, or painful skin or sores on your body
Urinating more often than normal
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.
For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use.
Boehringer Ingelheim is working on potential breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. For more information, please visit www.boehringer-ingelheim.com/us/.