"With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. "Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings." The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo® and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023. "The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn's disease and ulcerative colitis, which affect nearly 1 in 100 Americans," said Michael Osso, President & CEO of the Crohn's & Colitis Foundation. "The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines." "This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis," said Steven Taylor, President & CEO of the Arthritis Foundation. "We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem." "Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis," said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. "We welcome the introduction of this additional formulation to expand the array of options available to our community." The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm. The FDA approved Cyltezo as an interchangeable biosimilar to Humira on October 15, 2021. The efficacy and safety of Cyltezo are supported by a large body of data, including the Phase III randomized VOLTAIRE-X comparative clinical trial, which studied the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira. To learn more about Cyltezo, please visit Cyltezo.com. Healthcare providers can learn more about Cyltezo at CylezoHCP.com. *For more information on interchangeability for Cyltezo, please refer to the Purple Book: https://purplebooksearch.fda.gov/. 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.
This information also applies to Adalimumab-adbm injection for subcutaneous 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
This important information also applies to Adalimumab-adbm injection for subcutaneous use. What is the most important information I should know about CYLTEZO? You should discuss the potential benefits and risks of CYLTEZO with your doctor. CYLTEZO is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking CYLTEZO 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 CYLTEZO and check you closely for signs and symptoms of TB during treatment with CYLTEZO, 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 CYLTEZO, 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 CYLTEZO, 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 CYLTEZO? 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. CYLTEZO patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting CYLTEZO. Are allergic to rubber or latex.
Are allergic to any CYLTEZO ingredients. Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
Have a baby and you were using CYLTEZO during your pregnancy. Tell your baby's doctor before your baby receives any vaccines. What should I watch for AFTER starting CYLTEZO? CYLTEZO 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. 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 CYLTEZO. 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 CYLTEZO. 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 breakthrough therapies that improve the lives of humans and animals. 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. Around 52,000 employees serve more than 130 markets in three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at https://www.boehringer-ingelheim.com/us/. Senior Associate Director, Human Pharma Communications