- Robust analytical, pharmacological, non-clinical and clinical data demonstrates that Cyltezo™ is biosimilar to Humira®*
RIDGEFIELD, Conn., Aug. 29, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo™, a biosimilar to Humira®, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:
"Cyltezo™ is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo™ has the potential to deliver significant benefits to many of these individuals."
The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo™ is biosimilar to Humira®.
The European Medicines Agency is expected to provide an opinion on the marketing authorization application for our biosimilar candidate in 2017.
Cyltezo™ is not commercially available at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of Cyltezo™, as another delivery option for patients.
About Cyltezo™ (adalimumab-adbm) injection, for subcutaneous use
Rheumatoid Arthritis: CYLTEZO is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis: CYLTEZO is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Psoriatic Arthritis: CYLTEZO is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis: CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease: CYLTEZO is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative Colitis: CYLTEZO is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of CYLTEZO has not been established in patients who have lost response to or were intolerant to TNF blockers.
Plaque Psoriasis: CYLTEZO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. CYLTEZO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
IMPORTANT SAFETY INFORMATION FOR CYLTEZO™
WARNING: SERIOUS INFECTIONS and MALIGNANCY
Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CYLTEZO if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with CYLTEZO prior to initiating therapy in patients:1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CYLTEZO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Hepatitis B Virus Reactivation
Congestive Heart Failure
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in immunology and oncology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here https://www.boehringer-ingelheim.us/biopharma/biosimilars 
Boehringer Ingelheim further builds on its commitment to immunology and oncology to develop biosimilars as high quality, safe, and effective treatment options to patients with autoimmune diseases and cancer. In addition to Cyltezo™ (adalimumab-adbm), Boehringer Ingelheim currently has BI 695502, a bevacizumab biosimilar candidate to Avastin®* in late stage development. Also ongoing is VOLTAIRE -X, an interchangeability study with Cyltezo™ and the U.S.-marketed formulation of Humira®, 40mg/0.8mL. All public information on our clinical trials is available on: http://clinicaltrials.gov/ .
*Humira®is a registered trademark of AbbVie, Inc. and Avastin®is a registered trademark of Genentech, Inc. (USA).
**(Four years of age and older)
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website  to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.
In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.