Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company’s interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases.
RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ --Boehringer Mannheim Group announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company’s interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases. “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. About Cyltezo *For more information on interchangeability for Cyltezo, please refer to the Purple Book: https://purplebooksearch.fda.gov/. About Biosimilars 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 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. What is CYLTEZO? This information also applies to Adalimumab-adbm injection for subcutaneous use. CYLTEZO is a medicine called a tumor necrosis factor (TNF) blocker. CYLTEZO is used:
Important Safety Information for CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use 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.
What should I tell my doctor BEFORE starting CYLTEZO? Tell your doctor about all of your health conditions, including if you:
Also tell your doctor about all the medicines you take. You should not take CYLTEZO 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 CYLTEZO? CYLTEZO can cause serious side effects, including:
Call your doctor or get medical care right away if you develop any of the above symptoms. The most common side effects of CYLTEZO 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 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:
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. CL-CTZ-100017 SEPT 2023 For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use. About Boehringer Ingelheim 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-102954 4/24 Media Contact: View original content to download multimedia:https://www.prnewswire.com/news-releases/us-fda-approves-high-concentration-citrate-free-formulation-of-cyltezo-adalimumab-adbm-injection-boehringer-ingelheims-interchangeable-biosimilar-to-humira-302132457.html SOURCE Boehringer Ingelheim Pharmaceuticals, Inc. |